Manufacturing Engineer (Contract)

RESPONSIBILITIES

Developing, implementing, and continuously improving manufacturing processes to enhance yield, reduce costs, and improve productivity.
Representing Process Engineering in R&D and Project Team meetings, providing technical expertise in technology transfers, analytical method development, validation, and process scale-up.
Conducting or managing process validations (IQ/OQ, OQ, PQ).
Troubleshooting production line issues related to yield, quality, and throughput.
Leading scaling up processes from development to full-scale manufacturing.
Supporting evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
Creating/updating manufacturing instructions, routings, bills of materials, and SOPs.

QUALIFICATIONS

Minimum 4-5+ years of experience of medical device manufacturing.
Experience with Design Transfer and Process Validations at external suppliers (CMO).
Write and execute associated validations.
Strong analytical and problem-solving skills (DOE, SPC, Six Sigma)
Knowledge on Class II/Class III medical device manufacturing and related quality system regulations.
Demonstrates ability to consistently meet proposed timelines, applying competent use of project planning and project management skills.
Excellent oral and written communication skills; ability to communicate with technical and non-technical audiences.
Ability to effectively provide direction and support to external partners/suppliers.
Experience with electromechanical assemblies is preferred
Design for Manufacturing experience is preferred.
Fixture development experience is preferred.
Experience in early stage of product development is preferred.

EDUCATION

Bachelors in Biomedical, Manufacturing, Mechanical Engineering, or related life sciences discipline
Six Sigma Certification.

a Medical Devices company located in MN