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Senior Biomedical Manufacturing Jobs in Minnesota

Fresenius Medical Care

Biomedical Technician

Duluth, MN · On-site

$25 - $33.25/hr

... Senior Director Technical Services, overseen by a Vice President of Technical Services and ... with manufacturer's specifications for the devices and test equipment used. • Completes all ...

Fresenius Medical Care

Biomedical Technician

Robbinsdale, MN · On-site

$26 - $34.25/hr

... Senior Director Technical Services, overseen by a Vice President of Technical Services and ... with manufacturer's specifications for the devices and test equipment used. • Completes all ...

Philips

External Manufacturing Leader

Plymouth, MN · On-site

$134K - $212K/yr

... at senior leadership levels, scalable processes from development to high-volume manufacturing * You have Bachelor's / Master's Degree in mechanical, biomedical, electrical or manufacturing ...

Philips

External Manufacturing Leader

Plymouth, MN · On-site

$134K - $212K/yr

... at senior leadership levels, scalable processes from development to high-volume manufacturing * You have Bachelor's / Master's Degree in mechanical, biomedical, electrical or manufacturing ...

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Senior Biomedical Manufacturing information

What is the difference between Senior Biomedical Manufacturing vs Biomedical Manufacturing Technician?

AspectSenior Biomedical ManufacturingBiomedical Manufacturing Technician
CredentialsBachelor's degree, certifications in GMP, ISO, or quality assuranceAssociate's degree or technical certification, on-the-job training
Work EnvironmentManufacturing facilities, quality control labs, R&D settingsProduction floors, assembly lines, equipment setup
Employer & Industry UsageBiotech firms, medical device companies, pharmaceutical manufacturersMedical device manufacturing plants, biotech companies

The main difference between Senior Biomedical Manufacturing and Biomedical Manufacturing Technician lies in experience, responsibilities, and qualifications. Senior roles typically involve overseeing production processes, quality assurance, and team leadership, requiring more advanced education and experience. Technicians focus on hands-on manufacturing, equipment operation, and assembly, often with technical certifications. Both roles are essential in the biomedical industry, but they differ in scope and seniority.

What is senior biomedical manufacturing?

Senior biomedical manufacturing involves overseeing the production of medical devices, equipment, or pharmaceuticals, ensuring quality control, compliance with regulations, and efficient processes. Professionals in this role often require knowledge of manufacturing protocols, regulatory standards like FDA or ISO, and may lead teams or projects within a biomedical production environment.

What are popular job titles related to Senior Biomedical Manufacturing jobs in Minnesota?

For Senior Biomedical Manufacturing jobs in Minnesota, the most frequently searched job titles are:

What job categories do people searching Senior Biomedical Manufacturing jobs in Minnesota look for?

The top searched job categories for Senior Biomedical Manufacturing jobs in Minnesota are:

Senior Biomedical Manufacturing jobs near you
Infographic showing various Senior Biomedical Manufacturing job openings in Minnesota as of August 2026, with employment types broken down into 88% Full Time, 4% Part Time, 1% Temporary, 4% Contract, and 3% Nights. Highlights an 96% Physical, 2% Hybrid, and 2% Remote job distribution.

Engineer II - Sustaining Engineer - Med Device

FLEX Vascular

Plymouth, MN • On-site

$96K - $118K/yr

Full-time

Posted 25 days ago

Job description

ENGINEER II -  Sustaining Engineering (Vascular Access Devices)

Position Summary

The Engineer II role supports the design, development, validation, and sustaining engineering of vascular access devices and their associated manufacturing processes. Working within established procedures and under general supervision, the Engineer role II independently executes defined engineering projects including test method development, process and equipment qualification, fixture design, and technical investigations and documents the results in compliance with the Quality Management System and applicable regulatory requirements. The role escalates novel or ambiguous technical problems to senior engineering staff and contributes to cross-functional design and process review activities.

Essential Duties and Responsibilities

Design and Development Support

Provide project support including device and component testing, protocol authoring, documentation of test results, data analysis, and preparation of technical reports in accordance with design control procedures.

Contribute to Design History File (DHF) and Device Master Record (DMR) content for assigned projects.

Design, model, and fabricate test and manufacturing fixtures, including CAD modeling and additive manufacturing (3D printing) of prototypes.

Participate actively in design and process reviews.

Test Method and Process Validation

Design and execute test method validations (TMV), measurement systems analysis (MSA) including Gage R&R studies, and designs of experiments (DOE); analyze and report results.

Support line validation and qualification activities including IQ, OQ, and PQ authoring protocols and reports and executing testing.

Develop and document statistical rationale for sampling plans, sample sizes, acceptance criteria, and confidence/reliability targets.

Risk Management and Quality Systems

Participate in risk management activities including PFMEA, DFMEA, and use-related FMEA (uFMEA), and contribute to the risk management file in accordance with ISO 14971.

Perform process mapping and support process characterization and improvement initiatives.

Author and assess engineering change orders (ECOs) and change control records, including impact and validation assessments.

Provide technical investigation support for nonconformances, CAPAs, and complaint investigations. Complaint reportability and regulatory decisions remain the responsibility of Quality Assurance and Regulatory Affairs.

Manufacturing and Supplier Support

Interact with suppliers and vendors to facilitate new manufacturing processes or changes to existing processes, including technical support during process transfers.

Perform product and component inspections in compliance with company policies and procedures.

Support shipping and receiving of commercial product and components as required.

Qualifications

Required

Bachelor's degree in Mechanical, Biomedical, Manufacturing, or a related engineering discipline.

2-5 years of engineering experience, preferably in medical device or another FDA-regulated manufacturing environment.

Working knowledge of design controls and validation principles (IQ/OQ/PQ, TMV, MSA).

Demonstrated ability to author clear technical protocols and reports suitable for a regulated document system.

Proficiency with 3D CAD software (e.g., SolidWorks) and standard office productivity tools.

Preferred

Familiarity with medical device standards and guidance documents.

Experience with statistical software (e.g., Minitab, JMP) and applied statistical methods.

Experience with GD&T and inspection method development.

Experience with catheter, guidewire, or other vascular access device manufacturing processes.

Experience working in an ISO Class 7/8 controlled environment.