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Medical Device Manager Jobs in Michigan (NOW HIRING)

aspensurgical

Sr Design Engineer

Caledonia, MI

... Medical Device Software Lifecycle Requirements) preferred. * Strong familiarity with the methods of Risk Management and Failure Mode Effects Analysis (FMEA) * Working knowledge of design history ...

Premier Care Logistics

Be Seen First

Warehouse/Inventory Associate

Petoskey, MI · On-site

$19 - $22/hr

Operations Manager About Us Premier Care Logistics (PCL) is an ISO 13485-certified third-party logistics (3PL) provider specializing in medical device storage, fulfillment, and distribution. We ...

Biovire

Process Development Manager

Brighton, MI · On-site

We are seeking a Manager, Process Development to lead technical transfer activities for sterile injectable pharmaceutical and medical device products while driving process robustness, manufacturing ...

Biovire

Manager, Process Development

Brighton, MI

We are seeking a Manager, Process Development to lead technical transfer activities for sterile injectable pharmaceutical and medical device products while driving process robustness, manufacturing ...

Biovire

Manager, Process Development

Brighton, MI · On-site

$100K - $120K/yr

We are seeking a Manager, Process Development to lead technical transfer activities for sterile injectable pharmaceutical and medical device products while driving process robustness, manufacturing ...

aspensurgical

Design Engineer

Caledonia, MI

Medical Device Product Development * Lead projects and evaluate design changes related to existing ... Manage project schedules, budgets, mitigating risks, and efficient solutioning of issues.

Aspen Surgical

Sr Design Engineer

Caledonia, MI · On-site

... Medical Device Software Lifecycle Requirements) preferred. * Strong familiarity with the methods of Risk Management and Failure Mode Effects Analysis (FMEA) * Working knowledge of design history ...

Aspen Surgical

Design Engineer

Caledonia, MI · On-site

Medical Device Product Development * Lead projects and evaluate design changes related to existing ... Manage project schedules, budgets, mitigating risks, and efficient solutioning of issues.

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Medical Device Manager information

What are the key skills and qualifications needed to thrive as a medical device manager?

To excel as a Medical Device Manager, you need a solid background in biomedical engineering, regulatory compliance, and product lifecycle management, often supported by a relevant degree and industry experience. Familiarity with quality management systems (such as ISO 13485), FDA or CE regulatory processes, and CRM or ERP software is typically required. Strong leadership, problem-solving, and communication skills help in guiding cross-functional teams and managing client relationships. These competencies ensure the safe, effective launch and maintenance of medical devices in a highly regulated market.

What is a medical device manager?

Medical Device Managers are professionals responsible for overseeing the development, production, and regulatory compliance of medical devices within healthcare organizations or manufacturing companies. They coordinate teams, manage product lifecycles, ensure products meet safety standards, and liaise with regulatory bodies such as the FDA. Their work helps ensure that medical devices are safe, effective, and brought to market efficiently. In addition, they may also handle budgeting, quality assurance, and post-market surveillance of devices.

What are some common challenges faced by medical device managers in ensuring regulatory compliance?

Medical Device Managers often encounter challenges in navigating complex and evolving regulatory requirements across different regions. Ensuring that products meet the standards set by agencies like the FDA or EMA requires continuous monitoring of changes in regulations, thorough documentation, and close collaboration with regulatory affairs and quality assurance teams. Additionally, balancing compliance with timely product development and market launch can be demanding, as even minor oversights can lead to delays or costly recalls.

What is the difference between Medical Device Manager vs Medical Equipment Coordinator?

AspectMedical Device ManagerMedical Equipment Coordinator
CertificationsRegulatory and management certifications, such as RAC or PMPBasic healthcare or equipment management certifications
Work EnvironmentHealthcare facilities, manufacturing companies, regulatory agenciesHospitals, clinics, equipment suppliers
Employer & IndustryMedical device companies, hospitals, biotech firmsHospitals, clinics, medical equipment vendors
Primary FocusOverseeing device development, compliance, and lifecycle managementManaging equipment inventory, maintenance, and distribution

The Medical Device Manager primarily focuses on overseeing the development, compliance, and lifecycle of medical devices, often requiring management certifications. In contrast, the Medical Equipment Coordinator handles equipment inventory, maintenance, and distribution within healthcare settings. Both roles are essential in healthcare but differ in scope and responsibilities.

What are the most commonly searched types of Medical Device jobs in Michigan? The most popular types of Medical Device jobs in Michigan are:
What are popular job titles related to Medical Device Manager jobs in Michigan? For Medical Device Manager jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Medical Device Manager jobs in Michigan look for? The top searched job categories for Medical Device Manager jobs in Michigan are:
What cities in Michigan are hiring for Medical Device Manager jobs? Cities in Michigan with the most Medical Device Manager job openings:
Medical Device Manager jobs near you
Infographic showing various Medical Device Manager job openings in Michigan as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, 1% Temporary, and 6% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.

Sr Design Engineer

aspensurgical

Caledonia, MI

Full-time

Re-posted 3 days ago

Job description

 

Summary

The Sr Design Engineer is responsible for Design medical devices to support the growth, cost profile, and business continuity of Aspen Surgical products while working in a collaborative team environment.

 

In This Position, You Will Have the Opportunity to:

  • Support design tasks associated with global revenue growth and margin improvement projects
  • Support organic growth functions of acquisitions and other business migrations
  • Support sustaining engineering functions of the organization to maintain business continuity

Medical Device Product Development

  • Execute medical device design history file activities to be compliant with applicable regulations
  • Conduct the development and evaluation of medical device designs which meet defined product requirements and that are optimized for safe clinical solutions, production, reliability, and overall cost effectiveness for the business
  • Provide technical assistance to various departments and individuals as necessary in the exploration of new opportunities
  • Evaluate proposed changes to existing products and complete deliverables required to implement the change through individual efforts or cross-functional teams
  • Ensure that product changes meet regulations as well as internal and external customer requirements
  • Troubleshoot and problem-solve efforts related to product design.
  • Conduct thorough engineering and data analysis.

Project Management

  • Responsible for project schedules, budgets, mitigating risks, and efficient solutioning of issues
  • Recommend and communicate project plans, track tasks, and manage time to meet project deadlines
  • Executive presence for communicating with leaders in a clear efficient manner

 

Global Collaboration

  • Work closely with the portfolio managers to understand clinical and commercial impacts.
  • Strong communication skills to convey design concepts to clinicians to obtain design direction
  • Work with manufacturing throughout the development phases to ensure that products are produced in a safe, efficacious, and quality manner while keeping within established time frames
  • Work with finance to develop product costing to understand impacts of material/design selections
  • Interface with vendors, manufacturing facilities, and various internal groups to resolve design and manufacturing issues of new and existing products
  • Provide peer mentoring and guidance to other engineers throughout the company

What You Need to Succeed in This Position

  • Bachelor of Science Degree in Engineering or closely related 4-year technical degree is required
  • 7+ years of medical device engineering experience preferred
  • PMP certification preferred
  • Regulated industry experience that includes, but not limited to, FDA 21CFR820.30, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements.
  • Working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards
  • Experience with IEC 60601 (Medical Electrical Equipment Safety and Performance Requirements) and/or IEC 62304 (Medical Device Software Lifecycle Requirements) preferred.
  • Strong familiarity with the methods of Risk Management and Failure Mode Effects Analysis (FMEA)
  • Working knowledge of design history & technical file within an auditing environment.
  • Working knowledge of statistical analysis of data used to meet or define design criteria
  • Project management experience to effectively manage and complete multiple projects simultaneously
  • Involvement with invention disclosures or patents
  • Business case development for product costing as it pertains to design
  • Preferred experience using engineering programs such as SolidWorks, Minitab, TOPS, similar.
  • Teamwork, effective communication, and positive attitude required to fit & grow culture
  • Effectively handles global interactions and collaborations while managing cultural differences.
  • Models clinical safety and quality first mindset
  • Takes initiative and proactively mitigates risks
  • Continuous education focused to advance job knowledge in medical device design & development
  • Excellent computer skills including but not limited to Microsoft Office Suite
  • On site job located in Caledonia, MI with 15% expected travel

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