Inspire Medical Systems · 13 hours ago
Senior Manufacturing Engineer
Minneapolis, MN
Full-time
Onsite
Senior Level
$109K/yr - $163K/yr
7+ years expInspire Medical Systems is revolutionizing the sleep industry with their innovative medical device designed for those living with Obstructive Sleep Apnea. The Senior Manufacturing Engineer will support end products built by multiple contract manufacturing facilities, focusing on resolving manufacturing issues and improving throughput to meet demand.
BiotechnologyHealth CareMedical DeviceTherapeutics
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
Production Support and Trouble Shooting
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
Support the transfer of new products and processes from process development to
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
Qualification
Required
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
Preferred
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
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.
Company
Inspire Medical Systems
Inspire Medical Systems develops implantable therapeutic devices for the treatment of obstructive sleep apnea.
1001-5000 employees
H1B Sponsorship
Inspire Medical Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (2)
2022 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$319.4MKey Investors
Amzak Capital ManagementOrbiMedMedtronic
2020-04-13Post Ipo Equity· $133.4M
2018-12-18Post Ipo Equity· $75M
2018-05-03IPO
Leadership Team
Tim Herbert
Chairman & CEO
Richard Buchholz
CFO
Recent News
2026-01-07
Company data provided by crunchbase