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Medical Device Operations Jobs in Minnesota (NOW HIRING)

Med Device Scientist II

Maple Grove, MN

$30 - $40/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Med Device Scientist II This Scientist II role supports the development and optimization of drug ... operation of analytical instrumentation such as chromatographic and spectroscopic systems where ...

New

Plant Manager

Minneapolis, MN · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Regulatory/FDA, medical device operations experience * Experience with MRP/Kanban, Regulatory/FDA, medical device operations What STERIS Offers We value our employees and are committed to providing a ...

Assembly - Medical

Minnetonka, MN · On-site

$18.25 - $22.50/hr

  • Medical

  • Dental

  • Life

  • Retirement

This role is with a leading medical device manufacturing organization, is seeking Operators to join ... Maintain accurate documentation for all manufacturing operations * Communicate effectively with ...

Medical Assembler

Minneapolis, MN · On-site

$18.75 - $23/hr

Complete production and Device History Records. Read and follow written manufacturing instructions ... Cross-train on different assembly operations. Assist with training new assemblers. Support Lean ...

Director of Operations

Fridley, MN · On-site

$144K - $200K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

The Director, Operations has overall responsibility for all areas of operation including Quality ... Medical device manufacturing experience is essential. * Experience working in a cleanroom ...

Director of Operations

Fridley, MN

$144K - $200K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

The Director, Operations has overall responsibility for all areas of operation including Quality ... Medical device manufacturing experience is essential. * Experience working in a cleanroom ...

Showing results 21-40

Medical Device Operations information

What is the difference between Medical Device Operations vs Medical Device Quality Assurance?

AspectMedical Device OperationsMedical Device Quality Assurance
Primary FocusManaging manufacturing, supply chain, and product deploymentEnsuring product quality, compliance, and safety standards
Required CertificationsRegulatory knowledge, manufacturing certificationsQuality management certifications, ISO standards
Work EnvironmentManufacturing plants, supply chain settingsQuality labs, compliance departments
Industry UsageUsed across production and logistics teamsUsed within quality control and regulatory teams

Medical Device Operations and Medical Device Quality Assurance roles often overlap but focus on different aspects of the product lifecycle. Operations centers on manufacturing and logistics, while Quality Assurance emphasizes compliance and safety. Both roles require regulatory knowledge and are essential in the medical device industry.

What are some common challenges faced by professionals in medical device operations, and how can they be addressed?

Professionals in Medical Device Operations often face challenges related to maintaining strict regulatory compliance, ensuring product quality, and managing cross-functional communication between manufacturing, quality assurance, and regulatory teams. Staying up to date with changing FDA or international regulations is essential, and frequent documentation or process audits can be demanding. Building strong organizational habits, leveraging digital tracking tools, and fostering open communication channels with other departments can help address these challenges and ensure smooth operations.

What is medical device operations?

Medical device operations refer to the processes and activities involved in the manufacturing, assembly, quality control, supply chain management, and distribution of medical devices. This field ensures that devices are produced efficiently, meet regulatory standards, and are delivered safely to healthcare providers and patients. Operations teams collaborate with engineering, quality assurance, and regulatory departments to maintain compliance and optimize production workflows. Their work is crucial for ensuring that medical devices are safe, effective, and readily available for patient care.

What are the key skills and qualifications needed to thrive in medical device operations?

To thrive in Medical Device Operations, you need a solid understanding of regulatory compliance, quality assurance, and supply chain management, often supported by a degree in engineering, life sciences, or business. Familiarity with quality management systems (QMS), FDA regulations, and software like ERP systems is typically required. Strong organizational skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These competencies are vital for delivering safe, high-quality medical devices efficiently and in accordance with rigorous industry standards.

What are the most commonly searched types of Medical Device Operations jobs in Minnesota?

The most popular types of Medical Device Operations jobs in Minnesota are:

What are popular job titles related to Medical Device Operations jobs in Minnesota?

For Medical Device Operations jobs in Minnesota, the most frequently searched job titles are:

What job categories do people searching Medical Device Operations jobs in Minnesota look for?

The top searched job categories for Medical Device Operations jobs in Minnesota are:

Infographic showing various Medical Device Operations job openings in Minnesota as of August 2026, with employment types broken down into 73% Full Time, 12% Part Time, 12% Contract, and 3% Nights. Highlights an 97% In-person, and 3% Remote job distribution.

Sr. Design Assurance Engineer - Medical Device

Resolution Medical

Fridley, MN • On-site

$120K - $150K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

This job post has expired today. Applications are no longer accepted.


Job description

Job Type
Full-time
Description
Job Summary:
The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.
Essential Functions:
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables
  • Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
  • Support and ensure internal & external audit responses and on-time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Provide support for biocompatibility and sterilization qualifications
  • Develop and lead other team members and provide work direction as required
  • May have 2-3 technicians assigned for inspection, testing and project support
  • Performs other functions as required

Requirements
Education, Experience, and Required Skills:
  • BS Industrial Engineering, Engineering or Business Degree
  • 8-15 years of medical device experience in Quality Operations, or equivalent experience
  • 1-3 years of direct or indirect supervisory experience preferred
  • Comprehensive understanding of FDA regulations, ISO 13485, ISO 14971

Preferred Skills:
  • Statistical and data analysis
  • Supervisory, Solid Management and Strong Leadership experience

Physical Requirements:
  • Prolonged periods sitting at a desk and working on a computer
  • Must be able to lift 25 pounds at times
  • Must have manual dexterity
  • Must have excellent hand-eye coordination
  • Must wear gown, gloves, and ear protection if applicable

Summary of Benefits
  • Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
  • Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
  • Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
  • Flexible Time Off Program
  • Paid Parental Leave
  • Paid Holidays
  • Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation
  • The typical base pay range for this role is between $120,000-150,000/year. Compensation will vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
  • 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.