Senior Manufacturing Engineer

1 week ago


Eden Prairie, Minnesota, United States Collagen Solutions Full time

Job Summary

The Senior Manufacturing Engineer will be based out of the Collagen Solutions headquarters in Eden Prairie, MN and will support a global biomaterial med tech organization. This role is a key member of the engineering team reporting to the Operations Manager.

Key Responsibilities

  • Support active manufacturing with a focus on continuous improvement projects and operational excellence.
  • Coordinate internal resources and third parties/vendors to ensure execution of projects.
  • Ensure that all projects are delivered on time, within scope and within budget.
  • Developing project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility.
  • Develop detailed project plans to track progress.
  • Measure project performance using appropriate systems, tools and techniques.
  • Report and escalate to management as needed.
  • Manage the relationship with the client and all stakeholders.
  • Perform risk management to minimize project risks.
  • Establish and maintain relationships with third parties/vendors.
  • Create and maintain comprehensive project documentation.
  • Present to the business and key stakeholders as appropriate.
  • Liaising with the Commercial and R&D teams as required, providing information for proposal development.
  • Actively support timely closure of CAPAs, Complaint & audit actions.
  • Ensure effective engineering disciplines are followed to deliver launches of new products that can be reliably & repeatedly manufactured.
  • Identify potential capacity and operation efficiency opportunities.
  • Ensure all activities are performed in accordance with relevant regulations or requirements.

Requirements

  • Bachelor's degree in engineering required.
  • 4+ years of medical device industry/med tech engineering experience required.
  • Design control/process validation experience required.
  • Thorough understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments required.
  • Advanced degree in technical discipline preferred.
  • Experience with transcatheter heart valve manufacturing and/or biomaterials preferred.

Knowledge & Skills

  • Demonstrated mastery level knowledge with:
  • Design controls.
  • Process validation.
  • Equipment design and procurement.
  • Safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals and materials.
  • Knowledge of effective engineering problem solving tools.
  • QMS change control.
  • Works independently within established procedures associated with the specific job function.
  • Must be able to adjust to shifting and sometimes unexpected priorities and new responsibilities.
  • Exceptional organizational, communication (verbal and written) and interpersonal skills.
  • Ability to lift and/or carry 50 lbs.


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