Senior Mechanical Design Engineer

elemed; Santa Barbara (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

elemed is seeking a Senior Product Development Engineer to lead end‑to‑end medical device development from concept through market launch. You will work closely with leadership to shape innovation, manage design controls, and drive risk management across projects.

The role offers freedom to shape new devices with colleagues across regulatory, quality, and manufacturing, with growth into leadership and potential direct reports as the product line expands.

Qualifications

• Eight or more years of product development experience in the medical device industry.
• Experience with design controls, risk management processes, and regulatory standards.
• Proficiency in SolidWorks for 3D modelling and technical drawings.
• Legally authorized to work in the United States without visa sponsorship.

Responsibilities

• Lead cross‑functional product development projects end‑to‑end, ensuring on‑time delivery and meeting quality standards.
• Translate clinical and customer needs into structured design requirements and drive risk management and design reviews.
• Build and evaluate prototypes with various materials, develop drawings, select materials, and liaise with suppliers to reach manufacturability.
• Design and execute process characterization and verification activities, including test methods and fixture design for regulatory submissions.
• Collaborate with clinicians, marketing, regulatory, quality and manufacturing to assess new technologies and production feasibility.
• Contribute to intellectual property activities, including invention disclosures and patent strategy discussions.
• Support design and process changes post‑launch, resolve technical issues, and drive continuous improvement.
• Mentor and develop junior engineers, acting as a technical reference for the team.

Skills

Product development

Design controls

Risk management

Regulatory standards

Mentoring

Tools

SolidWorks

Job description

Eight years building medical devices at scale, and you still feel like you're maintaining rather than creating. What if the next move put you in charge of what gets invented?

The Company

This company occupies one of the most specific niches in medical device development. There is, by their own account, one meaningful competitor in the world, and that competitor is based in Europe. The addressable market is small, the specialism is deep, and the work they produce reaches patients directly.

Despite that focus, they carry the financial weight of a multinational parent with revenues well north of ten billion euros. Locally, the team is around 70 people. That combination gives you a startup pace and a flat structure without the cash anxiety that usually comes with it.

Culturally, the people here value open-mindedness, perseverance, and a willingness to have your ideas challenged. They are not looking for someone who needs certainty before they move. They want someone who stays positive when the obstacles stack up, because in a team this size, the obstacles are everyone's problem.

The Opportunity

Innovation at this company has been competing for attention against a heavy MDR remediation workload, and it is losing. This Senior Product Development Engineer role exists to change that, giving a dedicated focus to new product creation that the team cannot currently sustain on its own.

You will work directly alongside the leadership team, shaping the direction of new devices from concept through to market. The role carries genuine freedom, and the responsibility that goes with it. There is no committee layer between a good idea and its development here.

Progression is built into the plan. As the new product introduction side of the business grows, the expectation is that the successful applicant will grow with it, potentially taking on direct reports and leading a dedicated NPI function within a couple of years. Beyond that, being part of a larger group means exposure to more complex device categories if that is where your ambitions take you over time.

SolidWorks is a daily tool here. Experience designing with silicone or thermoplastics will land well, given the materials at the core of the product range. Corporate medical device development experience is what they are after, around eight years or more, though exceptional candidates who are slightly under that mark will not be dismissed out of hand.

What You'll Be Doing

• Lead cross-functional product development projects end-to-end, from design input through to verified, manufacturable output, keeping deliverables on track and quality requirements intact throughout.
• Translate clinical and customer needs into structured design requirements, then drive risk management, design reviews, and verification activities to make sure the finished product is both safe and clinically relevant.
• Build and evaluate prototypes using a range of materials and techniques, develop drawings and specifications, select appropriate materials, and work with suppliers to bring designs into manufacturable reality.
• Design and execute process characterisation and verification activities, including test method development and fixture design, documenting everything to the standard regulatory submissions demand.
• Collaborate with clinicians, marketing, regulatory, quality, and manufacturing colleagues to develop novel devices and assess new technologies, keeping an eye on both clinical relevance and production feasibility.
• Contribute to intellectual property activities, including invention disclosures and patent strategy discussions, helping build a defensible portfolio around new innovations.
• Support design and process changes post-launch, resolving technical issues and driving continuous improvement where it matters most.
• Mentor and develop junior engineers, acting as a technical reference point for colleagues building their own expertise in device development.

What We're Looking For

• Eight or more years of product development experience in the medical device industry, with a clear track record of taking innovative concepts through design controls and into the market.
• Demonstrable command of design control processes, risk management frameworks, and the regulatory standards that govern medical device development.
• Strong proficiency in SolidWorks for 3D modelling and technical drawing of medical devices.
• Legally authorised to work in the United States without visa sponsorship.