Manufacturing Engineer Wire Harness

Process Engineering and Strategic Design

Develop and optimize complex manufacturing workflows and workstation layouts using Lean Manufacturing methodologies.

Oversee and approve 3D/2D designs in Solid Works for fixtures, lay boards, and high-precision component prototypes.

Define the strategic roadmap for connector applications and fine wire termination, evaluating new manufacturing technologies.

Coordinate New Product Introduction (NPI) cycles from the initial design phase through to mass production.

Quality Leadership:
Lead CAPA investigations and head multidisciplinary teams for the development and updating of Process FMEAs.

Design, approve, and oversee the execution of equipment and production line validation protocols (IQ/OQ/PQ).

Authorize Standard Operating Procedures (SOPs), technical drawings, and data analysis reports for regulatory audits.

Guarantee strict process compliance with ISO 13485, 21 CFR 820 standards, and IPC/WHMA-A-620 acceptability criteria.

• Education:
  
  Bachelor’s Degree in Electromechanical, Electrical, Industrial, Manufacturing Engineering, or related field.
• Experience:
  
  5+ years of experience as an engineer within the medical device industry. Proven track record in electromechanical assembly and wire harnesses.
• Technical Knowledge:
  Advanced proficiency in Solid Works; deep expertise in line transfers and medical validation protocols; expert use of statistical software (Minitab).
• Languages:
  
  Advanced English proficiency B2+ to interface with global corporate clients and regulatory bodies.

Partner with the world's leading medical device companies to accelerate the development and manufacturing of innovative medical devices.

Honesty, Excellence, Accountability, Respect & Teamwork (HEART) as a part of their daily interactions with customers, peers and their communities.