Position: Senior Product Development Engineer
Location: Remote
Industry: Medical Device
Reports To: Director of Engineering
A Medical Device client is seeking a highly skilled and experienced Senior Product Development Engineer with a strong background in design and R&D to join their dynamic team. My client is known for designing diagnostic equipment that is used in a range of clinical setting to help diagnose and treat different neurological disorders.
Key Responsibilities:
- Lead the design and development of new medical devices from concept to commercialization.
- Conduct feasibility studies and risk assessments to ensure product viability and safety.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure seamless product development.
- Utilize advanced CAD software to create detailed mechanical designs and prototypes.
- Perform engineering analysis, including FEA and CFD, to validate design integrity and performance.
- Develop and execute test protocols to verify product functionality and compliance with industry standards.
- Ensure all designs comply with relevant regulatory requirements (e.g., FDA, ISO 13485).
- Mentor and guide junior engineers, fostering a culture of continuous improvement and innovation.
- Stay current with industry trends, emerging technologies, and regulatory changes to drive product innovation.
Qualifications:
- Bachelor’s or Master’s degree in Mechanical Engineering or a related field.
- 7 years of experience in product development within the Medical Device industry.
- Proven track record of successfully bringing medical devices from concept to market.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and engineering analysis tools (e.g., ANSYS, COMSOL).
- Strong understanding of regulatory requirements and standards (e.g., FDA, ISO 13485).
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
- Experience with project management and leading cross-functional teams is a plus.
