Position: As a Senior Product Engineer, you will collaborate with interdisciplinary teams including clinicians, researchers, engineers, and quality, commercial, and regulatory professionals to drive the advancement of our product portfolio. Your role will encompass both new product development to expand our clinical applications and sustaining engineering to enhance the performance and usability of the our system based on user feedback and company objectives.
Responsibilities:
- Lead and contribute to all phases of product development, including conceptualization, risk analysis, design validation, regulatory compliance, and post-market surveillance.
- Gain deep insights into clinical needs, workflows, and user environments through direct observation, prototyping, and clinical simulations.
- Stay abreast of evolving regulatory and commercial landscapes to ensure product compliance and competitiveness.
- Contribute to scientific publications, clinical reports, and regulatory submissions to support product advancement.
Skills:
- Demonstrated proficiency in analytical thinking, problem-solving, and effective communication.
- Ability to balance strategic planning with agile execution to iterate rapidly on product concepts.
- Experience collaborating across technical, commercial, regulatory, and clinical teams.
- Strong background in medical device development, including expertise in quality management systems, risk management, international standards, and FDA guidelines.
- Proficiency in rapid prototyping techniques for both hardware and software, including 3D modeling.
- Experience with sterile or disposable medical devices is desirable.
- Familiarity with surgical navigation or 3D medical imaging data (e.g., CT, MRI) is advantageous.
Benefits:
- Competitive salary and performance-based bonuses. Competitive salary range is $90,000 - $120,000 annually.
- Comprehensive health and wellness benefits package.
- Retirement savings plan with company matching.
- Flexible work arrangements, including remote work options.
- Professional development opportunities and tuition reimbursement.
- Collaborative and inclusive work environment with opportunities for growth and advancement.
.png)
