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Senior Process Engineer

Hcjy Fa Us2 Oraclecloud Com CX 1 · Stafford, TX, United States; US-Stafford, Stafford, TX, US · On Site · Active · Oracle Recruiting Cloud / Fusion HCM

Job facts

FieldValue
CompanyHcjy Fa Us2 Oraclecloud Com CX 1
TitleSenior Process Engineer
Normalized title-
Department / teamEngineering
LocationStafford, TX, United States
Work modelOn Site
Employment typeFull Time
Salary-
Statusactive
ATS providerOracle Recruiting Cloud / Fusion HCM
Posted / first seen2026-05-29 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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Linked records

CompanyHcjy Fa Us2 Oraclecloud Com CX 1
Source063b269b-849a-4216-8d0d-8fc4f7efa6f5
ATS providerOracle Recruiting Cloud / Fusion HCM

Description

Description About CooperSurgical CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com . Work location: Stafford, TX (on-site) Scope: The Senior Process Engineer is a key individual contributor responsible for the development, optimization, validation, and sustainment of manufacturing processes supporting medical device products. This role partners cross‑functionally with Quality, Manufacturing, R&D, and Supply Chain to ensure robust, compliant, and cost‑effective processes throughout the product lifecycle while meeting all applicable regulatory and quality standards. Job Summary: CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare. The Senior Manufacturing Engineering at CooperSurgical is responsible for driving manufacturing excellence and optimizing production processes for our medical device and fertility products. The Senior Manufacturing Engineer plays a critical role in driving integration projects, implementing lean principles, improving process efficiency, and fostering a culture of continuous improvement. Responsibilities Lead the design, development, and implementation of manufacturing processes for new and existing medical device products. Identify opportunities to improve process capability, efficiency, yield, and cost through data‑driven analysis. Develop process flow diagrams, PFMEAs, control plans, and work instructions to support stable manufacturing operations. Serve as a technical expert and escalation point for complex manufacturing process issues. Investigate process deviations, nonconformances, and complaints; drive root cause analysis and implement effective corrective and preventive actions (CAPA). Support production ramp‑ups, line transfers, and scale‑up activities. Plan and execute process validation activities (IQ/OQ/PQ) in compliance with FDA QSR, ISO 13485, and applicable global regulatory requirements. Ensure processes are compliant with design controls, risk management, and quality system procedures. Author and review validation protocols, reports, and technical documentation. Apply Lean, Six Sigma, or other continuous improvement methodologies to enhance process robustness. Support cost‑reduction initiatives without compromising quality or regulatory compliance. Establish and monitor key process metrics to drive performance improvements. Collaborate with R&D during design transfer to ensure manufacturability and scalability. Partner with Quality Engineering to ensure ongoing compliance and risk mitigation. Work closely with Manufacturing, Supply Chain, and external suppliers to support sustained performance. Mentor and provide technical guidance to junior engineers and technicians. Influence best practices and engineering standards across the organization. Lead technical aspects of cross‑functional projects as assigned. Travel: may be required to attend meetings or visit manufacturing sites. Approximately less than 5% Qualifications Knowledge, Skills and Abilities: In-depth knowledge of relevant quality standards and regulations, including ISO 13485, 21 CFR 820, MDSAP Work Environment: Occasionally lift to 35 pounds. Production / Clean Room / Warehouse / Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day. Experience: 7+ years of progressively responsible experience in process engineering within a regulated manufacturing environment; medical device experience strongly preferred Strong understanding of FDA QSR, ISO 13485 and risk management principles Proven experience with root cause analysis and structured problem-solving methodologies Education: Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, Chemical or related field) required; Advanced degree preferred. Must have strong knowledge in: Process validation (IQ/OQ/PQ) Ideally both in transferring/scaling up existing processes as well as developing new processes Our Benefits: As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team. To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

Full job record

Job IDa79324e7046da58a2a37b56c3dc8db8ea2d0eeba
Org IDfd5c005d-2102-408b-80a5-9404893f9b97
Source ID063b269b-849a-4216-8d0d-8fc4f7efa6f5
Board ID063b269b-849a-4216-8d0d-8fc4f7efa6f5
Provideroracle_hcm
Provider Job Key11284
TitleSenior Process Engineer
Normalized Title—
Statusactive
Activeyes
Location TextStafford, TX, United States; US-Stafford, Stafford, TX, US
DepartmentEngineering
Team—
Employment Typefull_time
Workplace Typeon_site
Remote Policy—
CountryUnited States
RegionTX
CityStafford
Salary RawDescription About CooperSurgical CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com . Work location: Stafford, TX (on-site) Scope: The Senior Process Engineer is a key individual contributor responsible for the development, optimization, validation, and sustainment of manufacturing processes supporting medical device products. This role partners cross‑functionally with Quality, Manufacturing, R&D, and Supply Chain to ensure robust, compliant, and cost‑effective processes throughout the product lifecycle while meeting all applicable regulatory and quality standards. Job Summary: CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare. The Senior Manufacturing Engineering at CooperSurgical is responsible for driving manufacturing excellence and optimizing production processes for our medical device and fertility products. The Senior Manufacturing Engineer plays a critical role in driving integration projects, implementing lean principles, improving process efficiency, and fostering a culture of continuous improvement. Responsibilities Lead the design, development, and implementation of manufacturing processes for new and existing medical device products. Identify opportunities to improve process capability, efficiency, yield, and cost through data‑driven analysis. Develop process flow diagrams, PFMEAs, control plans, and work instructions to support stable manufacturing operations. Serve as a technical expert and escalation point for complex manufacturing process issues. Investigate process deviations, nonconformances, and complaints; drive root cause analysis and implement effective corrective and preventive actions (CAPA). Support production ramp‑ups, line transfers, and scale‑up activities. Plan and execute process validation activities (IQ/OQ/PQ) in compliance with FDA QSR, ISO 13485, and applicable global regulatory requirements. Ensure processes are compliant with design controls, risk management, and quality system procedures. Author and review validation protocols, reports, and technical documentation. Apply Lean, Six Sigma, or other continuous improvement methodologies to enhance process robustness. Support cost‑reduction initiatives without compromising quality or regulatory compliance. Establish and monitor key process metrics to drive performance improvements. Collaborate with R&D during design transfer to ensure manufacturability and scalability. Partner with Quality Engineering to ensure ongoing compliance and risk mitigation. Work closely with Manufacturing, Supply Chain, and external suppliers to support sustained performance. Mentor and provide technical guidance to junior engineers and technicians. Influence best practices and engineering standards across the organization. Lead technical aspects of cross‑functional projects as assigned. Travel: may be required to attend meetings or visit manufacturing sites. Approximately less than 5% Qualifications Knowledge, Skills and Abilities: In-depth knowledge of relevant quality standards and regulations, including ISO 13485, 21 CFR 820, MDSAP Work Environment: Occasionally lift to 35 pounds. Production / Clean Room / Warehouse / Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day. Experience: 7+ years of progressively responsible experience in process engineering within a regulated manufacturing environment; medical device experience strongly preferred Strong understanding of FDA QSR, ISO 13485 and risk management principles Proven experience with root cause analysis and structured problem-solving methodologies Education: Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, Chemical or related field) required; Advanced degree preferred. Must have strong knowledge in: Process validation (IQ/OQ/PQ) Ideally both in transferring/scaling up existing processes as well as developing new processes Our Benefits: As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team. To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
Salary Min—
Salary Max—
Salary Currency—
Salary Periodday
Source URLhttps://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/11284
Apply URLhttps://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/11284
First Seen At2026-05-31 17:56:25Z
Last Seen At2026-06-06 18:54:57Z
Last Checked At2026-06-06 18:54:57Z
Last Changed At2026-06-06 11:19:22Z
Inactive At—
Source Posted At2026-05-29 15:21:27Z
Source Updated At—
Raw Payload Uris3://job-postings-prod-raw-590183727216/raw/provider=oracle_hcm/board=hcjy.fa.us2.oraclecloud.com|CX_1/date=2026-06-06/2026-06-06T18-54-41-336Z-a5965b54189b18264a41117402013b6b0f9a2ca665e465fc49b0f52e26911a85.json
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    "ExternalDescriptionStr": "<p class=\"elementtoproof\"><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\"><strong>About CooperSurgical</strong></span></span></p><p style=\"background-color: white; margin-bottom: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at&nbsp;</span></span><a href=\"http://www.coopersurgical.com\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">www.coopersurgical.com</span></span></a><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">.&nbsp;</span></span></p><p style=\"margin-bottom: 0in;\">&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Work location:</strong> Stafford, TX (on-site)</span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Scope:&nbsp;</strong></span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">The Senior Process Engineer is a key individual contributor responsible for the development, optimization, validation, and sustainment of manufacturing processes supporting medical device products. This role partners cross‑functionally with Quality, Manufacturing, R&amp;D, and Supply Chain to ensure robust, compliant, and cost‑effective processes throughout the product lifecycle while meeting all applicable regulatory and quality standards.</span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Job Summary:</strong></span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare.<span>&nbsp; </span>The Senior Manufacturing Engineering&nbsp;at CooperSurgical is responsible for driving manufacturing excellence and optimizing production processes for our medical device and fertility products. The Senior Manufacturing Engineer plays a critical role in driving integration projects, implementing lean principles, improving process efficiency, and fostering a culture of continuous improvement.</span></p>",
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As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.</span></p>",
    "InternalQualificationsStr": "<p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Knowledge, Skills and Abilities:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">In-depth knowledge of relevant quality standards and regulations, including ISO 13485, 21 CFR 820, MDSAP</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Work Environment:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Occasionally lift to 35 pounds.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Production / Clean Room / Warehouse / Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.&nbsp;</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Experience:</strong></span></p><ul style=\"list-style-type: disc;\"><li style=\"background-color: white; line-height: 13.5pt; margin-bottom: 0in; margin-top: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\">7+ years of progressively responsible experience in process engineering within a regulated manufacturing environment; medical device experience strongly preferred</span></li><li style=\"background-color: white; line-height: 13.5pt; margin-bottom: 0in; margin-top: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\">Strong understanding of FDA QSR, ISO 13485 and risk management principles</span></li><li style=\"background-color: white; line-height: 13.5pt; margin-bottom: 0in; margin-top: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\">Proven experience with root cause analysis and structured problem-solving methodologies</span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Education:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, Chemical or related field) required; Advanced degree preferred.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Must have strong knowledge in:</span></span><ul style=\"list-style-type: circle;\"><li><p style=\"background-color: white; line-height: 13.5pt;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Process validation (IQ/OQ/PQ)&nbsp;</span></span></p></li><li style=\"background-color: white; line-height: 13.5pt; margin-bottom: 0in; margin-top: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\">Ideally both in transferring/scaling up existing processes as well as developing new processes</span></li></ul></li></ul><p style=\"background-color: white;\">&nbsp;</p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><strong>Our Benefits:</strong></span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.</span></p>",
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    "ExternalResponsibilitiesStr": "<ul style=\"list-style-type: disc;\"><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Lead the design, development, and implementation of manufacturing processes for new and existing medical device products.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Identify opportunities to improve process capability, efficiency, yield, and cost through data‑driven analysis.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Develop process flow diagrams, PFMEAs, control plans, and work instructions to support stable manufacturing operations.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Serve as a technical expert and escalation point for complex manufacturing process issues.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Investigate process deviations, nonconformances, and complaints; drive root cause analysis and implement effective corrective and preventive actions (CAPA).</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Support production ramp‑ups, line transfers, and scale‑up activities.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Plan and execute process validation activities (IQ/OQ/PQ) in compliance with FDA QSR, ISO 13485, and applicable global regulatory requirements.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Ensure processes are compliant with design controls, risk management, and quality system procedures.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Author and review validation protocols, reports, and technical documentation.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Apply Lean, Six Sigma, or other continuous improvement methodologies to enhance process robustness.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Support cost‑reduction initiatives without compromising quality or regulatory compliance.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Establish and monitor key process metrics to drive performance improvements.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Collaborate with R&amp;D during design transfer to ensure manufacturability and scalability.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Partner with Quality Engineering to ensure ongoing compliance and risk mitigation.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Work closely with Manufacturing, Supply Chain, and external suppliers to support sustained performance.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Mentor and provide technical guidance to junior engineers and technicians.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Influence best practices and engineering standards across the organization.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Lead technical aspects of cross‑functional projects as assigned.</span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Travel:</strong> may be required to attend meetings or visit manufacturing sites. Approximately less than 5%</span></p>",
    "InternalResponsibilitiesStr": "<ul style=\"list-style-type: disc;\"><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Lead the design, development, and implementation of manufacturing processes for new and existing medical device products.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Identify opportunities to improve process capability, efficiency, yield, and cost through data‑driven analysis.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Develop process flow diagrams, PFMEAs, control plans, and work instructions to support stable manufacturing operations.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Serve as a technical expert and escalation point for complex manufacturing process issues.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Investigate process deviations, nonconformances, and complaints; drive root cause analysis and implement effective corrective and preventive actions (CAPA).</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Support production ramp‑ups, line transfers, and scale‑up activities.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Plan and execute process validation activities (IQ/OQ/PQ) in compliance with FDA QSR, ISO 13485, and applicable global regulatory requirements.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Ensure processes are compliant with design controls, risk management, and quality system procedures.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Author and review validation protocols, reports, and technical documentation.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Apply Lean, Six Sigma, or other continuous improvement methodologies to enhance process robustness.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Support cost‑reduction initiatives without compromising quality or regulatory compliance.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Establish and monitor key process metrics to drive performance improvements.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Collaborate with R&amp;D during design transfer to ensure manufacturability and scalability.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Partner with Quality Engineering to ensure ongoing compliance and risk mitigation.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Work closely with Manufacturing, Supply Chain, and external suppliers to support sustained performance.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Mentor and provide technical guidance to junior engineers and technicians.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Influence best practices and engineering standards across the organization.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"background-color: white; color: black; font-family: Arial, sans-serif;\">Lead technical aspects of cross‑functional projects as assigned.</span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Travel:</strong> may be required to attend meetings or visit manufacturing sites. Approximately less than 5%</span></p>",
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    "ShortDescriptionStr": "About CooperSurgical\n\nCooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. \n\nWork location: Stafford, TX (on-site)",
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