Senior Product Development Engineer

We are seeking a highly skilled and innovative Senior Product Development Engineer with expertise in medical devices and tissue engineering to lead the design, development, commercialization, and early product management of innovative products in the medical device and regenerative medicine space. This role will manage complex projects and drive the technical and strategic development of advanced medical device and tissue-engineered solutions. This person will work in a collaborative startup environment, contributing to cutting-edge innovations that push the boundaries of medical applications.

Responsibilities:

• Lead the design, development, and testing of advanced medical devices and tissue-engineered products.
• Oversee the integration of personalized design, advanced materials, 3D printing, and engineering techniques to bring innovative products to market.
• Manage the entire product development lifecycle, from concept through commercialization, ensuring compliance with regulatory requirements (e.g., FDA, ISO, CE).
• Collaborate with cross-functional teams, including clinicians, researchers, scientists, regulatory specialists, and manufacturing teams, to align product goals and deliverables.
• Develop and optimize processes for manufacturing and scaling tissue-engineered products and medical devices.
• Conduct design reviews, risk assessments, and failure mode analyses to ensure product quality and safety.
• Mentor and guide junior engineers and cross-functional team members, fostering a culture of innovation and continuous improvement.
• Generate intellectual property through patents and technical publications.
• Communicate findings through technical reports and presentations for internal and external stakeholders.
• Interface with key stakeholders, including customers, regulatory bodies, and external collaborators, to ensure project success.
• Perform other duties as directed.

Qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Materials Science, Tissue Engineering, or related field (Master’s or Ph.D. preferred).
• 7+ years of experience in product development within the medical device or tissue engineering industry.
• Proven track record of leading successful product launches, including regulatory approval processes (e.g., FDA 510(k), PMA, or CE marking).
• Expertise in design, advanced materials, tissue engineering, and/or regenerative medicine technologies.
• Strong knowledge of medical device design controls, risk management, and quality standards (e.g., ISO 13485, ISO 14971).
• Proficiency in CAD software, material characterization techniques, and data analysis tools.
• Demonstrated experience in process optimization and technology transfer to manufacturing.
• Exceptional leadership, project management, and problem-solving skills.
• Excellent communication skills for presenting technical concepts to diverse audiences.

Preferred Skills and Attributes:

• Experience with 3D printing, bioprinting, and advanced manufacturing techniques for medical device and tissue-engineered products.
• Familiarity with device only and drug-device combination products and regulatory implications.
• Hands-on experience with preclinical and clinical trial support.
• Certification in project management (e.g., PMP) or quality systems (e.g., Six Sigma, Lean Manufacturing).
• Strategic thinking with the ability to align technical development with business goals.
• Comfortability with human and animal anatomy, device implantation and explantation, tissue processing, both virtually and in person.

What We Offer:

• Leadership opportunities in a pioneering field of regenerative medicine and medical devices.
• Access to state-of-the-art facilities and cutting-edge technologies.
• Competitive salary, equity options, and a comprehensive benefits package.
• A dynamic and collaborative work environment that values innovation and excellence.

If you are a results-driven engineer passionate about shaping the future of healthcare through advanced tissue-engineered medical devices, we invite you to join our team and make a lasting impact.

Pay: $100,000.00 - $119,000.00 per year

Benefits:

• Health insurance
• Retirement plan
• Stock options

People with a criminal record are encouraged to apply

Work Location: In person