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Remote Medical Device Engineer Jobs in Novi, MI (NOW HIRING)

WELLMEI MOLD

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Market Development Manager - Injection Mold/Injection Molding

Novi, MI · Remote

$80K - $120K/yr (+ commission)

... and medical device manufacturers. * Establish and maintain relationships with key decision-makers, including purchasing, sourcing, engineering, and project management teams. * Promote Wellmei ...

Varsity Tutors

Biomedical Engineering Tutor

Detroit, MI · Remote

$18 - $40/hr

Ability to explain signal processing for biosignals, finite element analysis, drug delivery systems, and medical device design principles while preparing students for biomedical engineering ...

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All JobsMedical Device Engineer JobsRemote Medical Device Engineer JobsRemote Medical Device Engineer Jobs in Novi, MI

Remote Medical Device Engineer information

See Novi, MI salary details

$20

$46

$90

How much do remote medical device engineer jobs pay per hour?

As of Sep 7, 2026, the average hourly pay for remote medical device engineer in Novi, MI is $46.76, according to ZipRecruiter salary data. Most workers in this role earn between $32.93 and $55.91 per hour, depending on experience, location, and employer.

What is a remote medical device engineer?

A Remote Medical Device Engineer designs, develops, and tests medical devices while working from a remote location. They ensure compliance with industry regulations and collaborate with cross-functional teams to improve device functionality and safety. Responsibilities may include CAD modeling, prototyping, software integration, and regulatory documentation. Remote engineers use digital tools to communicate with teams and manage development processes efficiently. Strong technical expertise and knowledge of medical device regulations are essential for this role.

What is a typical workday like for a remote medical device engineer?

A typical workday as a Remote Medical Device Engineer often involves designing and reviewing device components using CAD software, participating in virtual meetings to coordinate with R&D, quality assurance, and regulatory teams, and conducting documentation for regulatory submissions. You may also troubleshoot technical issues, analyze test data, and provide design updates based on feedback or test results. Regular communication with colleagues across different time zones is common, requiring flexibility and excellent organizational skills. The remote nature of the role typically offers autonomy and flexibility while maintaining close collaboration with diverse, cross-functional teams to ensure projects progress smoothly.

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

To thrive as a Remote Medical Device Engineer, you need a solid background in biomedical engineering or related fields, along with experience in product development, regulatory compliance, and device testing. Familiarity with CAD software, FDA regulations (such as 21 CFR Part 820), and risk management systems is typically required, and certifications like PMP or Six Sigma can be advantageous. Strong problem-solving abilities, effective remote communication skills, and the ability to collaborate across distributed teams are crucial soft skills. These qualifications ensure that engineers can design safe, compliant devices and contribute effectively to remote, cross-functional teams.

What cities near Novi, MI are hiring for Remote Medical Device Engineer jobs?

Cities near Novi, MI with the most Remote Medical Device Engineer job openings:

Remote Medical Device Engineer jobs near you
Infographic showing various Remote Medical Device Engineer job openings in Novi, MI as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, 5% Contract, and 1% Nights. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $97,255 per year, or $46.8 per hour.

Sr Mgr, QA/Quality Engineer, Device & Combination Products

ESPERION THERAPEUTICS INC

Ann Arbor, MI • Remote

$166K - $175K/yr

Full-time

Medical, Retirement, PTO

Re-posted 11 days ago

Job description

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.


Esperion Quality Philosophy: Quality is in all we do because all we do is for our patients. 

Esperion’s passion for quality is an integral part of our company culture and is embedded in every aspect of the organization. We are committed to applying the highest quality standards to develop and deliver safe, effective pharmaceutical products that significantly improve the quality of life for the patients and clinical trial participants we serve.


Esperion is a fully remote‑based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance‑based bonus program, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Senior Manager, Quality Assurance / Quality Engineer – Device and Combination Products

This role is responsible for the quality of assigned suppliers/contract manufacturers to ensure business objectives are met with regards to on time delivery of product while assuring compliance to Esperion requirements, applicable external regulations, and standards. 


This position serves as the Quality Assurance subject matter expert for combination products, ensuring appropriate control strategies are in place for drug substance, drug product, and device components, and partners closely with Quality Control, Regulatory Affairs, Technical Operations, and external partners to maintain inspection readiness.



Preferred Location: Remote – US

Essential Duties and Responsibilities*

  • Provide in‑depth technical and scientific leadership to contract service providers and internal stakeholders related to Quality Engineering for device and combination products.
  • Serve as the primary QA/QE technical and project management liaison with CDMOs and external testing laboratories supporting drug substance, drug product, and device/combination component testing.
  • Review and approve development, release, and stability data for routine manufacturing, investigations, and deviations involving drug substance, drug product, device and combination products.
  • Conduct quality review and approval of critical quality records and documents, including batch records, deviations, investigations, CAPAs, change controls, complaints, risk management, validation protocols and reports, stability documentation, Design History File, and Annual Product Reviews (APR). 
  • Ensure compliance with applicable combination product regulatory requirements, including 21 CFR Parts 4, 210, 211, 820, ISO 13485 and other relevant regulations. 
  • Release 
  • Provide quality oversight of external suppliers and contract manufacturers involved in manufacturing, assembly, filling, testing, and packaging. 
  • Support regulatory submissions and act as the QA/QE lead during FDA, EU, and partner audits and inspections, including those involving combination product or device‑related scope.
  • Support Medical Device Reporting activities.
  • Assist with supplier qualifications and monitoring compliance with Quality Agreements. 
  • Serve as a Quality representative for cross-functional activities supporting device and combination product development and commercial supply. 
  • Partner with QC and Technical Device Engineer on investigations, change controls, CAPAs, and risk assessments.
  • Support qualification of alternate manufacturing sites, laboratories, service suppliers, and device component suppliers.
  • Lead or co‑lead cross‑functional Technical Operations projects and CDMO oversight activities.
  • Support complaint handling and investigation activities. 

*Additional duties and responsibilities as assigned.

Qualifications (Education & Experience)

Required Qualifications

  • Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific discipline from an accredited college or university.
  • 8+ years of progressive Quality Assurance or Quality Engineering experience within the medical device or drug–device combination product industry.
  • Direct experience supporting medical devices and/or drug–device combination products in a regulated GxP environment.
  • Strong working knowledge of:
    • 21 CFR Parts 210/211 (cGMPs)
    • 21 CFR Part 4 (Combination Products)
    • ISO 13485 and ISO 14971
    • ISTA
    • Applicable elements of 21 CFR Part 820
  • Proven experience managing global external CDMOs and contract testing laboratories.
  • Experience supporting regulatory inspections and audits, including preparation and response activities.
  • Strong project management, communication, and stakeholder‑influencing skills in a matrixed environment.

Preferred Qualifications

  • Experience working within ISO 13485‑aligned quality systems.
  • Experience supporting EU MDR or global device regulatory submissions.
  • Background supporting combination products such as inhalers, prefilled syringes, autoinjectors, or other delivery systems.
  • Experience contributing to CMC sections of U.S. or EU regulatory filings involving combination products.
  • Familiarity with data integrity requirements and lifecycle management of analytical methods for combination products.
  • Experience with electronic Quality Management Systems (e.g., Veeva QMS)
  • Experience setting up and maintaining Design History Files, Risk Management Files, as well as other device and combination product records.

Additional Requirements

  • Proficiency with MS Office, laboratory, and quality systems (LIMS, QMS, EDMS).
  • Demonstrated alignment with Esperion’s values and culture.
  • Ability to work effectively in a fully remote environment.
  • Moderate domestic and international travel required (up to 25% annually).