ResponsibilitiesThe Senior R&D Engineer is responsible for leading product and process development activities related to our combination drug-device platforms. This role contributes to the design, optimization, and validation of innovative medical devices, ensuring alignment with quality, regulatory, and clinical requirements while mentoring junior engineers.
Key Accountabilities- Lead the design, development, and testing of combination drug-device systems including drug-coated balloon catheters.
- Drive concept generation, prototyping, and product improvement initiatives.
- Manage design control documentation and ensure compliance with FDA 21 CFR Part 820 and ISO 13485 requirements.
- Plan and execute verification and validation studies.
- Collaborate cross-functionally with Analytical Chemistry, Manufacturing, and Quality teams.
- Provide technical oversight during technology transfer and process scale-up.
- Support regulatory submissions with design and technical documentation.
- Mentor and guide junior engineers in technical and professional development.
- Identify and implement process improvements to enhance design efficiency.
- Participate in design reviews, FMEA, and risk assessments.
QualificationsRequired Qualifications- Bachelor's degree in Mechanical, Biomedical, or Chemical Engineering.
- 5+ years of R&D or product development experience in the medical device industry.
- In-depth knowledge of design controls, risk management, and validation processes.
- Strong CAD skills (SolidWorks preferred).
- Proven leadership and project management experience.
Preferred Qualifications- Experience with drug-device combination products or interventional cardiology devices.
- Advanced degree (M.S. or Ph.D.) in engineering or related discipline.
- Knowledge of polymer coatings, drug release kinetics, or sterilization processes.
Key Competencies- Technical innovation and problem-solving ability.
- Excellent documentation and communication skills.
- Strong leadership and mentoring skills.
- Collaboration and cross-functional influence.
- Commitment to quality and regulatory compliance.
Working Conditions- Office and laboratory environments.
- May require standing or bending for extended periods.
- Light lifting (up to 25 lbs.).
- Occasional travel (
Preferred QualificationsPay / CompensationThe expected pre-tax pay rate for this position is $97,900 - $130,900 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
