Senior Manufacturing Engineer

Inspire Medical Systems Inc. • Minneapolis, MN

7h • $109,000 - $163,000 • Onsite

About The Position

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
The Senior Engineer will support end products built by multiple contract manufacturing facilities. This role will focus on resolving manufacturing issues and improving throughput and yields to maintain product supply to meet demand. Successful candidate will demonstrate knowledge related to working in a regulated industry with ISO13485 & 21CFR 820 GMP experience.

Requirements

• B.S. degree in an Engineering discipline (Manufacturing, Mechanical, Industrial, etc.)
• Minimum of 7+years of relevant experience
• 5+years increasingly complex engineering responsibilities in a manufacturing environment

Nice To Haves

• M.S. degree in an Engineering discipline
• Minimum of 7+ 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

Responsibilities

• Provide expert technical support for Manufacturing to meet or exceed goals
• Develop and implement process and product improvements
• 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. Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
• Provide engineering support to manufacturing operation
• Address related issues arising on the production floor. Lead inter-disciplinary teams to resolve high profile production issues and document recommended corrective actions using the quality systems procedures. (NCMR & CAPA). Ability to lead Failure Investigations
• Ensures processes and procedures are in compliance with internal procedures, GMP, and global regulations
• Process Validation: Develop master validation plans to evaluate process repeatability and stability through IQ/OQ/TMV and PQ processes
• Equipment and Fixturing: Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters. May collaborate on design with suppliers to fulfill equipment and fixturing requirements
• Serve as the technical manufacturing expert to provide feedback during the development cycle and represent operations with the introduction into manufacturing, initial ramp, and stabilization of processes.
• Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling
• Design arrangement of machines within plant facilities to ensure most efficient and productive layout
• Design sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance
• Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation
• Provide follow-up reporting as needed
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.

Benefits

• 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. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees