Manufacturing Engineer Job at Inspire Medical Systems I
Inspire Medical Systems has developed the only FDA-approved neurostimulation technology that transforms the lives of people with moderate to severe sleep apnea. We are a ground-breaking, fast-growing company where the patient’s outcome is first and foremost our top priority. If you want to become part of a purpose-driven company and directly help to transform lives, this is the perfect career opportunity for you!
Inspire Medical Systems is looking for an experienced Manufacturing Engineer to 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.
MAIN DUTIES/RESPONSIBILITIES
- Provide expert technical support for Manufacturing to meet or exceed goals and objectives.
- Develop and implement process and product improvements. Typically, projects of complex scope and wide magnitude.
- Define and generate all required documentation in support of manufacturing protocols, reports, manufacturing instructions and procedures. These include: Engineering protocols, reports, manufacturing instructions and procedures. Ensure compliance with GMPs and internal protocol. 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 global regulations.
- Qualification and Validation: Develop plans to evaluate process repeatability and stability through equipment qualification and process validation.
- 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 operations. 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.
QUALITY SYSTEM RESPONSIBILITIES
- 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.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
QUALIFICATIONS
Educational Requirements:
Required:
- B.S. degree in an Engineering discipline (Manufacturing, Mechanical, Industrial, etc.)
- M.S. degree in an Engineering discipline
- Minimum of 3 years of relevant experience, or advanced degree with a minimum of 1 years of relevant experience
- 3-5 years increasingly complex engineering responsibilities in a manufacturing environment
- 2 years experience working within 21 CFR 820 & ISO 13485 compliant manufacturing environments
- Engineering experience with active implantable medical devices
Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status with regard to public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.
Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep dot com.
Inspire Medical Systems participates in E-Verify.
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