Description

You will own the end-of-line (EOL) process validation, regulatory compliance, and manufacturing engineering for medical devices.

This role is on-site.

Responsibilities

• Develop and execute process validation strategies, including IQ, OQ, and PQ protocols for cleaning, packaging, and machining.
• Ensure regulatory compliance with FDA 21 CFR 820 and ISO 13485, participating in audits and maintaining updated knowledge.
• Analyze validation data to identify trends, compile reports, and drive continuous improvement initiatives.
• Create and maintain controlled technical documents, including prints, procedures, bills of materials, and routers.
• Collaborate cross-functionally with Quality, Engineering, and Manufacturing to resolve issues and implement cleaning strategies.

Required Skills

• Bachelor’s degree from an ABET-accredited school in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering Technology, or Aerospace Engineering.
• 4+ years of experience in manufacturing engineering, with preference for the orthopedic or medical device industry.
• Hands-on experience with process validation, risk assessments, and equipment qualification.
• Proficiency in supporting processing applications such as machining, finishing, forging, casting, heat treating, and molding.
• Ability to conduct feasibility studies, estimate product costs, and analyze capital equipment capacity and capability requirements.
• Strong project management skills for developing project plans, schedules, and change controls.

Preferred Skills

• Experience with specific medical device regulations and audit preparation.
• Background in biomedical or bioengineering technologies.

Key Skills

Education

Bachelor's degree