What are the responsibilities and job description for the Product Development Engineer III / Medical Device position at Intellectt Inc?
Job Title: Product Development Engineer III / Medical Device
Location: Mansfield, MA (On-site)
Key Responsibilities:
- Lead and contribute to medical device new product development and sustaining engineering initiatives.
- Work with technical files and ensure compliance with medical device regulations including EU MDR, MDD, FDA 21 CFR Part 820, Part 11, ISO 13485, IEC 60601, IEC 62304, and ISO 14971.
- Support QMS, technical file, DHF, and risk management file remediation efforts.
- Execute requirement traceability, draft protocols, conduct data analysis, and develop test methods and validations.
- Apply DFMEA, PFMEA, GD&T, and design documentation processes in product development.
- Collaborate with stakeholders, project managers, and vendors to ensure seamless execution of product development activities.
- Utilize MS Project and MS Office tools for project planning and documentation.
Must-Have Qualifications:
- Bachelor’s degree in Engineering (Master’s degree in Mechanical or Biomedical Engineering preferred).
- Minimum 5 years of experience in medical device development.
- At least 3 years of experience in product development.
- Strong understanding of medical device verification & validation (V&V) processes.
Nice-to-Have Qualifications:
- Experience with EU MDR remediation in product development.
- 3-4 years of direct R&D experience.
- Knowledge of requirement traceability to site inputs.
- Experience in drafting protocols, test method development, and test validation.
