Product Engineer III

About the Role

We are seeking a Product Engineer III to join a high-performing Sustaining Engineering team focused on advancing cardiovascular medical technologies. This role plays a key part in implementing product and process changes, maintaining compliance, and supporting ongoing innovation across a diverse portfolio of medical devices.

Key Responsibilities

• Implement and coordinate changes to approved medical products, including packaging and labeling.
• Maintain and update product technical files in line with global regulatory requirements (CE and international).
• Develop and execute test plans for design verification and validation.
• Create 3D models and technical drawings for products, tools, and fixtures.
• Conduct mechanical and material evaluations to characterize and qualify product concepts and processes.
• Support cross-functional teams, including Quality, R&D, Regulatory, and Manufacturing, throughout product lifecycle updates.
• Contribute to the development of intellectual property (IP).
• Independently manage assigned work packages and project deliverables.

Qualifications

Required:
Bachelor’s degree in Biomedical or Mechanical Engineering (or equivalent).
Minimum 4 years of relevant engineering experience, ideally in the medical device industry.
Strong understanding of product development, sustaining engineering, and change control processes.
Proven ability to write technical documentation, reports, and protocols.
Excellent written and verbal communication skills in English.
Proficiency with CAD software (e.g., SolidWorks).

Preferred:
Experience with statistical analysis and Design of Experiments (DOE); Minitab knowledge is a plus.
Familiarity with mechanical, thermal, and biomechanical testing of medical devices or biomaterials.
Experience with finite element analysis (FEA) and additive manufacturing (3D printing).

Key Attributes

Analytical and problem-solving mindset with attention to detail.
Strong technical curiosity and a drive to improve existing products and processes.
Collaborative approach, able to work effectively in cross-functional environments.