Medical Device Product Developer
5 days ago
We are seeking a highly skilled Medical Device Product Developer to join our team at Kerecis LLC. As a key member of our product development team, you will be responsible for developing and commercializing next-generation medical products.
Job SummaryThe successful candidate will have a strong background in engineering, with a focus on medical device development. You will work closely with our team to design, develop, and test new products, ensuring they meet the highest quality standards.
Responsibilities- Monitor emerging technologies and manufacturing processes to identify opportunities for business growth.
- Apply foundational engineering principles to develop and test new products through our stage-gate process.
- Maintain detailed documentation throughout all phases of product development.
- Design, perform, and report on laboratory experiments, methods development, and product testing.
- Run product feasibility and pre-clinical tests in-house and manage outsourcing to third-party facilities.
- Write engineering test plans, design requirements, and design failure mode and effect analysis (DFMEA).
- Collaborate with project managers, engineers, specialists, and others to prepare technical documentation and work instructions.
- Communicate project progress effectively using presentation tools in weekly group meetings.
- Proficiency in an engineering role in the medical device field.
- Strong work ethic to deliver high-quality products on time and within budget.
- Self-motivated with demonstrated leadership skills.
- Aptitude with Microsoft Office products, such as Word, Excel, and PowerPoint.
- Ability to interact with multidisciplinary colleagues in a team environment.
- Organizational and record-keeping skills.
- Excellent communication skills (oral and written) with presentation technique.
- Bachelor's degree from an accredited college or university in an engineering discipline (e.g., biomedical, mechanical, materials science, chemical).
- 5+ years' experience in a product development role in the medical device industry.
- Familiarity with preclinical biocompatibility and animal studies is a plus.
- Prior work history in FDA and/or ISO-regulated medical product development (21 CFR 820 and ISO 13485).
- Experience planning, conducting, and reporting on verification and validation tests.
- Experience using design of experiments, test method development, statistical analysis techniques, and data analysis tools.
$120,000 - $150,000 per annum, depending on experience.
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