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Senior Manager, Device Development and Manufacturing

674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001 · Lexington, MA, US, Lexington, MA · Remote · Deleted · $164,000–$175,000 / year · ADP Workforce Now Recruiting

Job facts

FieldValue
Company674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001
TitleSenior Manager, Device Development and Manufacturing
Normalized title-
Department / team-
LocationLexington, MA, United States
Work modelRemote / Remote
Employment typeFull Time
Salary$164,000–$175,000 / year
Statusdeleted
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-04-06 / 2026-05-31
Changed / last seen2026-06-13 / 2026-06-11

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PageWhat it containsOpen
Company jobsActive postings from 674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001.Open
Company breakdownsRole, location, ATS, and work model facets for this company.Open
ATS provider jobsActive postings observed through ADP Workforce Now Recruiting.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in Lexington.Open
Work model jobsActive Remote postings.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

Company674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001
Source4f2fb43e-6107-4f34-ab57-87d29ca5c68a
ATS providerADP Workforce Now Recruiting

Description

Kiniksa is seeking a highly motivated Senior Manager, Device Development and Manufacturing to join our Drug Product Development team in Lexington, MA. Reporting to the Director, Device Development and Manufacturing, this individual will play a key role in developing Kiniksa’s drug-device combination products. This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. Responsibilities (including, but not limited to) : Manage combination product design history file (DHF) functioning as SME on design control and risk management. Manage external vendors and partners (CMDOs and device testing labs) to advance project milestones Develop, manage, execute, and support human factors studies. Conduct use-related risk assessments Execute design verification and validation Conduct impact assessments for Change Control, including DHF/RMF assessments Author and review of regulatory submissions and responses Assist in platform device selection and packaging design for new programs by performing feasibility tests Summarize and communicate project updates to stakeholders Qualifications and Experience: Requires a Bachelor's degree in mechanical or biomedical engineering related field of study with 8+ years of relevant industry experience; or Master’s degree (preferred) with 6+ years of relevant industry experience Knowledge of applicable regulations/standards, such as 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366, Part 4, etc. with a focus on Design Controls and Risk Management Previous experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes, inhalers Ability to manage multiple priorities and work with ambiguity Strong commitment to compliance and ethical standards Ability to travel up to 5% Salary is commensurate with experience Kiniksa Benefits Summary - USA The pay range for this position is $164,000 - $175,000. Compensation is subject to change commensurate with industry standards and the candidate’s relevant experience and qualifications. Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Full job record

Job ID860ac8c23fe9c88e1475a9176d22b5a6b1286802
Org ID952c9fe5-daa7-4a0c-b3f8-5d560f99a753
Source ID4f2fb43e-6107-4f34-ab57-87d29ca5c68a
Board ID4f2fb43e-6107-4f34-ab57-87d29ca5c68a
Provideradp_workforcenow
Provider Job Key601794
TitleSenior Manager, Device Development and Manufacturing
Normalized Title—
Statusdeleted
Activeno
Location TextLexington, MA, US, Lexington, MA
Department—
Team—
Employment Typefull_time
Workplace Typeremote
Remote Policyremote
CountryUnited States
RegionMA
CityLexington
Salary Raw164000.00 To 175000.00 (USD) Annually
Salary Min164,000
Salary Max175,000
Salary CurrencyUSD
Salary Periodyear
Source URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=674a37b7-4b6a-4f38-a5e8-50a609cdab78&ccId=19000101_000001&lang=en_US&type=JS&jobId=601794&jwId=9201775466201_1
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First Seen At2026-05-31 18:30:04Z
Last Seen At2026-06-11 12:06:22Z
Last Checked At2026-06-13 12:25:24Z
Last Changed At2026-06-13 12:25:24Z
Inactive At2026-06-13 12:25:24Z
Source Posted At2026-04-06 18:08:00Z
Source Updated At—
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    "requisitionDescription": "<div><div><div><div><div><div style='margin: 0px;padding: 0px;color: rgb(0, 0, 0);font-family: \"Segoe UI\", \"Segoe UI Web\", Arial, Verdana, sans-serif;font-size: 12px;font-style: normal;font-weight: 400;text-align: start;text-indent: 0px;text-transform: none;background-color: rgb(255, 255, 255);' data-pasted=\"true\"><p style=\"margin: 0px 0px 10.6667px;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: transparent;color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 19.425px; font-family: arial, sans-serif;\"><span style=\"margin: 0px; padding: 0px; border-bottom: 1px solid transparent;\">Kiniksa</span><span style=\"margin: 0px; padding: 0px;\"> is seeking a highly motivated Senior Manager, Device Development and Manufacturing </span><span style=\"margin: 0px; padding: 0px;\">to join our Drug Product Development team in Lexington, MA. Reporting to the Director, Device Development and Manufacturing, this individual will play a key role in developing </span><span style=\"margin: 0px; padding: 0px; border-bottom: 1px solid transparent;\">Kiniksa&rsquo;s</span><span style=\"margin: 0px; padding: 0px;\"> drug-device combination products.</span>&nbsp;</span></p><p style=\"margin: 0px 0px 10.6667px;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: transparent;color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 19.425px; font-family: arial, sans-serif;\"><span style=\"margin: 0px; padding: 0px;\">This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.</span>&nbsp;</span></p><p style=\"margin: 16px 0px;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: transparent;color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 18px; font-family: arial, sans-serif; font-weight: bold;\"><span style=\"margin: 0px; padding: 0px;\">Responsibilities </span></span><span style=\"margin: 0px; padding: 0px; font-size: 14px; font-style: italic; line-height: 18px; font-family: arial, sans-serif; font-weight: bold;\"><span style=\"margin: 0px; padding: 0px;\">(including, but not limited to)</span></span><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 18px; font-family: arial, sans-serif; font-weight: bold;\"><span style=\"margin: 0px; padding: 0px;\">:</span></span><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 18px; font-family: arial, sans-serif;\">&nbsp;</span></p><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Manage combination product design history file (DHF) functioning as SME on design control and risk management.&nbsp;</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Manage external vendors and partners (CMDOs and device testing labs) to advance project milestones</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Develop, manage, execute, and support human factors studies. Conduct use-related risk assessments</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Execute design verification and validation</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Conduct impact assessments for Change Control, including DHF/RMF assessments</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Author and review of regulatory submissions and responses</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Assist in platform device selection and packaging design for new programs by performing feasibility tests</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Summarize and communicate project updates to stakeholders</span></span></li></ul><p style=\"margin: 0px 0px 10.6667px;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: transparent;color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 19.425px; font-family: arial, sans-serif; font-weight: bold;\"><span style=\"margin: 0px; padding: 0px;\">Qualifications and Experience:</span></span><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 19.425px; font-family: arial, sans-serif;\">&nbsp;</span></p><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Requires a </span><span style=\"margin: 0px; padding: 0px; border-bottom: 1px solid transparent;\">Bachelor&#39;s degree in mechanical</span><span style=\"margin: 0px; padding: 0px;\"> or biomedical engineering related field of study with 8+ years of relevant industry experience; or </span><span style=\"margin: 0px; padding: 0px; border-bottom: 1px solid transparent;\">Master&rsquo;s</span><span style=\"margin: 0px; padding: 0px;\"> degree (preferred) with 6+ years of relevant industry experience</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Knowledge of applicable regulations/standards, such as 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366, Part 4, etc. with a focus on Design Controls and Risk Management</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Previous experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes, inhalers</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Ability to manage multiple priorities and work with ambiguity</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 18px;\"><span style=\"margin: 0px; padding: 0px;\">Strong commitment to compliance and ethical standards</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"margin: 0px; padding: 0px; line-height: 19.425px;\"><span style=\"margin: 0px; padding: 0px;\">Ability to travel up to 5%</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><span data-contrast=\"auto\" lang=\"EN-US\" class=\"TextRun SCXW118215532 BCX8\" style=\"margin: 0px; padding: 0px; line-height: 18px;\"><span class=\"NormalTextRun SCXW118215532 BCX8\" style=\"margin: 0px; padding: 0px;\">Salary is commensurate with experience</span></span></li><li style=\"margin-left: 24px; font-family: arial, sans-serif; font-size: 14px;\"><a class=\"Hyperlink SCXW118215532 BCX8\" href=\"https://www.kiniksa.com/join-us\" target=\"_blank\" rel=\"noreferrer noopener\" style=\"margin: 0px; padding: 0px; text-decoration: none; color: inherit; font-family: arial, sans-serif; font-size: 14px;\"><span class=\"SCXW118215532 BCX8\" style=\"margin: 0px;padding: 0px;\"><span data-contrast=\"none\" lang=\"EN-US\" class=\"TextRun Underlined SCXW118215532 BCX8\" style=\"margin: 0px; padding: 0px; color: rgb(5, 99, 193); text-decoration: underline; line-height: 18px;\"><span class=\"NormalTextRun SCXW118215532 BCX8\" data-ccp-charstyle=\"Hyperlink\" style=\"margin: 0px;padding: 0px;\">Kiniksa Benefits Summary - USA</span></span></span></a></li></ul></div><div style='margin: 0px;padding: 0px;color: rgb(0, 0, 0);font-family: \"Segoe UI\", \"Segoe UI Web\", Arial, Verdana, sans-serif;font-size: 12px;font-style: normal;font-weight: 400;text-align: start;text-indent: 0px;text-transform: none;background-color: rgb(255, 255, 255);'><p style=\"margin: 0px;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: rgb(255, 255, 255);color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 18px; font-family: arial, sans-serif;\">&nbsp;</span></p><p style=\"margin: 0px;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: rgb(255, 255, 255);color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 18px; font-family: arial, sans-serif;\"><span style=\"margin: 0px; padding: 0px; background-color: rgb(255, 255, 255);\">The pay range for this position is $164,000 - $175,000. Compensation is subject to change commensurate with industry standards and the candidate&rsquo;s relevant experience and qualifications. </span></span><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 18px; font-family: arial, sans-serif; background-color: rgb(255, 255, 255);\">&nbsp;</span></p><p style=\"margin: 0px;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: rgb(255, 255, 255);color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 18px; font-family: arial, sans-serif;\">&nbsp;</span></p><p style=\"margin: 0px;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: rgb(255, 255, 255);color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px; padding: 0px; font-size: 14px; line-height: 18px; font-family: arial, sans-serif;\"><span style=\"margin: 0px; padding: 0px; border-bottom: 1px solid transparent;\">Kiniksa</span><span style=\"margin: 0px; padding: 0px;\"> is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</span>&nbsp;</span></p><p style=\"margin: 0px 0px 10.6667px 48px;padding: 0px;font-weight: normal;font-style: normal;vertical-align: baseline;background-color: transparent;color: windowtext;text-align: left;text-indent: 0px;\"><span style=\"margin: 0px;padding: 0px;font-size:15px;line-height: 19.425px;font-family: Calibri, Calibri_EmbeddedFont, Calibri_MSFontService, sans-serif;\">&nbsp;</span></p></div></div></div></div></div></div>\n",
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}
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