Manufacturing Process Engineer

2 days ago


Minneapolis, Minnesota, United States Inspire Medical Systems I Full time
Product Supply Chain Expert Needed

About Inspire Medical Systems I

We are a leader in the medical device industry, revolutionizing the sleep industry with our innovative products. Our mission is to improve the lives of those living with Obstructive Sleep Apnea (OSA).

Career Opportunity

As a Manufacturing Process Engineer at Inspire Medical Systems I, you will play a critical role in supporting end products built by multiple contract manufacturing facilities. Your expertise will be instrumental in resolving manufacturing issues and improving throughput and yields to maintain product supply.

Your Responsibilities

  • Provide expert technical support for manufacturing operations to meet or exceed goals and objectives.
  • Develop and implement process and product improvements, focusing on complex scope and wide magnitude projects.
  • Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.
  • Generate all required documentation in support of manufacturing test protocols and reports, utilizing statistical support and Design of Experiments (DOE) when developing recommendations.
  • Address production-related issues and lead inter-disciplinary teams to resolve high-profile production issues, documenting recommended corrective actions using quality systems procedures (NCMR & CAPA).
  • Ensure processes and procedures comply with internal procedures, GMP, and global regulations.
  • Collaborate on equipment and fixturing requirements to fulfill operational needs, potentially designing arrangements for machines within plant facilities to ensure efficient and productive layouts.
  • Design sequence of operations and specify procedures for the fabrication of tools and equipment that affect product performance.

What We Offer

We provide a highly competitive benefits package, including:

  • Multiple health insurance plan options.
  • Employer contributions to Health Savings Account.
  • Dental, Vision, Life, and Disability benefits.
  • 401k plan + employer match.
  • Identity Protection.
  • Flexible time off.
  • Tuition Reimbursement.
  • Employee Assistance program.
  • All employees have the opportunity to participate in the ownership and success of Inspire Medical Systems I through equity awards and the Employee Stock Purchase Program.

$85,000 - $120,000 per year

Requirements

  • B.S. degree in an Engineering discipline (Manufacturing, Mechanical, Industrial, etc.).
  • Minimum of 1-2 years of relevant experience.
  • 1-2 years increasingly complex engineering responsibilities in a manufacturing environment.

Preferred Qualifications

  • M.S. degree in an Engineering discipline.
  • Minimum of 1-2 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
  • 5+ years increasingly complex engineering responsibilities in a manufacturing environment.
  • 5+ years experience working within 21 CFR 820 & ISO 13485 compliant manufacturing environments.
  • Engineering experience with active implantable medical devices.

EEO Statement

Inspire Medical Systems I is an equal opportunity employer and complies with applicable laws governing non-discrimination in employment in every location in which we have facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.



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