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Medical Device Design Jobs (NOW HIRING)

Aspen Surgical

Sr Design Engineer

Caledonia, MI · On-site

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 ...

Senseye

Design Quality Engineer, SaMD

Austin, TX · On-site

$100K - $125K/yr

We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...

Alcon

Principal Engineer Device Design

Fort Worth, TX · On-site

Applies knowledge of materials and manufacturing methods for medical devices * Generate detailed ... and Reports; and design control through ECN, and Windchill. * Support existing device and ...

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How much do medical device design jobs pay per hour?

As of Sep 1, 2026, the average hourly pay for medical device design in the United States is $49.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $59.62 per hour, depending on experience, location, and employer.

What is a medical device design?

A Medical Device Design job involves creating, developing, and improving medical devices to ensure they are safe, effective, and user-friendly. Professionals in this field work with engineers, regulatory specialists, and healthcare professionals to meet industry standards and patient needs. They use computer-aided design (CAD) software, prototyping, and testing methodologies to refine devices before production. The role requires knowledge of biomechanics, materials science, and regulatory guidelines such as FDA and ISO standards.

What are some typical challenges faced in a medical device design role?

Medical Device Design professionals often encounter challenges such as balancing innovative design with stringent regulatory requirements and ensuring devices are both effective and safe for patient use. Navigating complex approval processes, collaborating with clinicians for feedback, and keeping up with rapidly evolving technologies can also be demanding. However, these challenges make the role dynamic and rewarding, as designers play a direct role in improving patient outcomes. Team-based problem solving and ongoing learning are key parts of the job, and successfully overcoming challenges can lead to career growth and leadership opportunities within the medical device industry.

What are the key skills and qualifications needed to thrive in medical device design, and why are they important?

Success in Medical Device Design requires a solid understanding of biomedical engineering, materials science, and human anatomy, often supported by a relevant engineering degree and experience in product development. Familiarity with CAD software, rapid prototyping tools, and regulatory standards such as FDA or ISO 13485 certification is common in the field. Strong problem-solving abilities, teamwork, and effective communication help professionals excel in multidisciplinary design teams. These competencies are crucial for creating safe, innovative medical devices that meet strict quality and regulatory requirements.

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Medical Device Design jobs near you
Infographic showing various Medical Device Design job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $103,662 per year, or $49.8 per hour.

Sr Design Engineer

Aspen Surgical

Caledonia, MI • On-site

Full-time

Re-posted 23 days ago

Job description

About Aspen
We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people's lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.
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

We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.

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