Product Development Engineer

2 days ago


Mahwah, New Jersey, United States Comrise Full time
Product Development Engineer

Comrise is seeking a highly skilled Product Development Engineer to join our team. As a key member of our product development team, you will be responsible for supporting the development and introduction of new orthopedic products.

Key Responsibilities:
  • Collaborate with cross-functional teams to take products from design concept to production ramp up.
  • Participate in multifunctional teams led by a Project Manager and be responsible for defined project deliverables.
  • Manage Engineering Change Notices for new products from creation to final approval.
  • Operate within Comrise's quality system to produce documentation such as process validations, equipment qualifications, dynamic control plans, inspection plans, and standard operating procedures.
  • Utilize Six Sigma process tools such as DMAIC, FMEA, DOE, Gage R&R, and SPC as required.
  • Create and execute equipment validation protocols for Factory Acceptance Testing, Supplier Acceptance Testing, and Equipment Qualifications as required.
  • Create and execute Process Qualification protocols as required.
Requirements:
  • Strong understanding of product development processes and quality systems.
  • Experience with Six Sigma process tools and methodologies.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.


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