Manufacturing Engineer — Medical Devices, ISO 13485 Expert
RevZero, Inc.
A dynamic manufacturing company in Chanhassen, MN is seeking a Manufacturing Engineer to optimize processes and ensure compliance with ISO 13485 standards. The role involves collaborating with various teams, utilizing SolidWorks for design, and innovating manufacturing solutions. Ideal candidates should have 3+ years of experience in regulated industries and a Bachelor's degree in a related field. #J-18808-Ljbffr RevZero, Inc.
$49 - $59 per hour
...$59.00/hr Title: Quality Engineer Location: Maple Grove, MN,... ...applicable standards (e.g., ISO 13485, ISO 1497, FDA QSR, EUMDR)... ...Engineering, preferably in medical device development. Strong knowledge... ...function Medical Equipment Manufacturing and Pharmaceutical...SuggestedContract work- ...Process Development Engineer II Department:... ...and transferring manufacturing processes that support... ...of customer medical devices within an ISO1348... ...discussions and providing expert guidance on... ...such as ISO, FDA, or GMP (as... ...required by ISO 13485, FDA 21 CFR part...SuggestedFull timeWork at office
$70k - $90k
...- $90,000.00/yr We’re looking for a Manufacturing Engineer who thrives in a fast-paced, collaborative... ...our manufacturing processes, ensure ISO 13485 compliance with rigorous standards,... ...manufacturing experience, ideally in medical devices or other highly regulated industries...SuggestedFull time$100k - $130k
...Verification & Validation Engineer is responsible for... ..., Assay, Quality, and Manufacturing) on V&V scope, schedules... ...in a regulated (FDA/ISO) environment. Proven... ...Preferred Experience Medical device/IVD product development... ...management (e.g., ISO 13485, ISO 14971), and successful...Suggested$66.22k - $86k
...hiring a Systems Verification Engineer I on its Continuation... ...Engineers, R&D, Quality, and Manufacturing to maintain product integrity... ...environment. Hearing aid, medical device, or audio/consumer... ...requirements (FDA 21 CFR Part 820, ISO 13485). Intermediate knowledge...SuggestedTemporary workWorldwide- Solventum is seeking a Senior Quality Engineer to enhance quality assurance for medical devices. This role involves investigating quality issues and ensuring regulatory compliance while collaborating with cross-functional teams. The ideal candidate will possess a Bachelor...Remote job
- Elucent Medical in Eden Prairie, MN is seeking a Systems Test Engineer to develop, maintain, and execute system-level verification... ...validation tests for medical device systems. You will collaborate with... ...approved procedures and FDA/ISO standards. Proficiency with scripting...
$32.69 - $45 per hour
HCLTech is seeking a highly talented and self-motivated Manufacturing Engineer to join its team in Plymouth, MN. This role emphasizes New Product Introduction and process development, requiring 5+ years of manufacturing engineering experience and a Bachelor’s degree in...Hourly pay- Join Abbott as a Sr. Manufacturing Engineer in Plymouth, MN. You will design manufacturing processes and manage projects to improve product quality... .... This role comes with excellent benefits including medical coverage, retirement plans, and support for career development...
- IMRIS, a leader in intraoperative MRI, is seeking a Senior Quality Engineer in Chaska, Minnesota. The role involves supporting medical device product quality assurance activities, including compliance with design control procedures and regulatory standards. The ideal candidate...
$105k - $115k
A leading medical device manufacturer in Maple Grove is seeking a Mid-Senior Level Engineer to enhance operational excellence. You will apply Lean tools to optimize high-volume manufacturing processes and lead continuous improvement initiatives. Ideal candidates will have...Full time$58.2k - $110.5k
A leading medical device company in Maple Grove, MN is seeking a Manufacturing Engineer I who will support and lead initiatives in the Balloon Catheter Assembly (BCA) business unit. The role involves monitoring equipment performance, troubleshooting production issues, and...$50 - $78 per hour
Contract Manufacturing Engineer Location: On‑site, Minneapolis Area, MN Pay Rate: $50-78 per hour Responsibilities Support manufacturing... ...related technical field. 4+ years of engineering experience in medical device, life sciences, or other regulated manufacturing...Hourly payContract workFreelance$80k - $95k
The Manufacturing Engineer will play a crucial role in ensuring that production processes are efficient, effective, and aligned with company... ...equipment. Visual acuity necessary for inspecting small medical device components. Ability to work in various positions including...Temporary work$121.6k - $151.9k
TE Connectivity is seeking a Staff Manufacturing Engineer in Plymouth, Minnesota. This role involves leading complex automation projects, ensuring compliance in a regulated medical environment, and acting as a technical specialist for site-level automation systems. The...- Elucent Medical Inc. in Eden Prairie, MN, seeks a Senior R&D Engineer in the Systems & Innovation group to advance platform initiatives and translate concepts into working prototypes. You will work with the CSIO and collaborate with Engineering, Quality, Regulatory, Clinical...
- ...growth. About the Role Manual Test Engineer responsible for verification and validation of embedded medical systems, including execution... ...testing for embedded medical devices Execute regression,... ...FDA guidelines, EC 62304, and ISO 13485 Experience contributing to Design...
$55.6k - $91.45k
...Position Summary: ? The Manufacturing Engineer supports the development, improvement... ...staff.? Follow GMP/IVD/ISO 13485 or similar regulatory... ..., life sciences, or med device industries is a plus Basic... ...in regulated industries (Medical Device, IVD, Pharma, Aerospace...Temporary workInternshipWork at officeWorldwideFlexible hours- ...key member of the Manufacturing team, the Principal Manufacturing Engineer will assist in creating... ...a subject matter expert across the... ...ensuring compliance with ISO standards and... ...s), preferably in medical device industry; Bachelor... ...knowledge of ISO 13485/ISO 9000 standards...Work at officeFlexible hours
$130k - $160k
...needed) Company Summary: Enterra Medical is a medical device company dedicated to a singular focus... ...seeking a skilled Principal Firmware Engineer with specialized experience in... ...with medical device standards, such as ISO 13485, IEC 62304, and FDA regulations, throughout...Work at office- ...initiatives. The successful candidate will ensure compliance with ISO 13485 and FDA standards while maintaining documentation and quality... ...the organization. This role requires a Bachelor’s degree in Engineering, 10 years of experience, and proven audit leadership. The...
- ...red-lines and format engineering documents per documentation... ...working within a GMP manufacturing environment would be... ...System. Knowledge of ISO 9001 standard required; knowledge of ISO 13485 is an advantage Prior... ...documentation of Life Science or Medical Device products. Strong word...Work experience placementWork at office
$121.6k - $151.9k
...Staff Manufacturing Engineer Posting Start Date: 4/22/26 At... ...the Minnesota Metals (Medical Subcomponents) Manufacturing... ...a regulated medical device environment. By... ...an in‑house technical expert for site‑level... ...Ensure compliance with ISO 13485, GMP, QSR, and internal...Local area$102.5k - $153.8k
...valued member of the Minnesota Metals (Medical Subcomponents) Manufacturing Engineering team at TE Connectivity, the... ...resolution in a regulated medical device manufacturing environment. The Senior... ...manufacturing environments (ISO 13485, GMP, QSR, or similar industries...Work experience placement- Elucent Medical Inc. is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies and submissions for medical devices. This role focuses on FDA 510(k) pathways, ensuring compliance throughout the product lifecycle. With a minimum of 7 years of experience...
$40 - $47 per hour
...solutions company located in Maple Grove is seeking a mid-senior level engineer for a contract position. The ideal candidate will have strong CAD/SolidWorks experience and a background in medical device development. Responsibilities include product development,...Contract work- .... The ideal candidate has a Bachelor's degree in Engineering or related field, with over 3 years of experience in the Medical Device industry and 2 years in a leadership role. Applicants should be knowledgeable about ISO standards and Lean/Six Sigma methodologies. This...Full time
$113k - $133k
...are seeking a Senior Manufacturing Engineer to provide technical... ...the subject matter expert in catheter and delivery... ...and maintain the Device Master Record (DMR) for... ...Regulation (21 CFR 820) ISO 13485 and applicable... ...engineering experience within medical devices or catheter-...Temporary workH1bLocal areaVisa sponsorshipWork visaFlexible hours- ...Saltera HR is proud to partner with a medical device manufacturing organization operating in a clean,... ...with Production, Quality, and Engineering on continuous improvement efforts Compliance... ...and Safety Follow GMP, CGMP, FDA, ISO 9001/13485, and internal SOPs Maintain...Work at office
- ...supplier of innovative, high-quality medical products focused on improving... ...to detail. Knowledge of the medical device industry and the FDA and ISO regulatory requirements preferred. Strong... ...CFR Part 820) and ISO standards (ISO 13485) preferred. Prior experience in document...
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