Nonin Medical, Inc. is a rapidly growing international medical device manufacturer that has been designing and distributing high quality medical monitoring devices since 1986. Headquartered in Plymouth, MN, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere. We are currently searching for a dynamic Supplier Manufacturing Engineer to join our Manufacturing Engineering Team.
Provide manufacturing engineering support for the manufacturing, testing and sourcing of products throughout the entire supply chain from development stages through high volume manufacturing at suppliers. This includes developing requirements, ensuring design for manufacturability, leading cost reduction initiatives, validation of processes, completing failure analysis and ensuring products produced meet requirements.
Please Note: No housing, transporting or relocation allowance is provided.
Essential Duties and Responsibilities:
- Provide engineering support for product design and process improvements to improve manufacturing efficiency, ensure product quality, and lower costs for new and existing products throughout the supply chain.
- Develop and maintain the documentation necessary, including external supplier documentation, to ensure consistent manufacture of products (processes, drawings, routings, and flow of materials throughout the supply chain).
- Define, procure and support test equipment at suppliers.
- Use project management skills and tools to investigate and lead projects for alternate component technologies for reduced cost or improved quality and reliability.
- Involvement with New Product Development (NPD) to ensure suppliers are involved in the development of specifications to promote Design for Manufacturability and ensure the integrity and clarity of engineering drawing requirements and expectations are communicated effectively.
- Resolve component and finished product failures and focus actions on the root cause. Assure supplier compliance to procedures and assist in supplier corrective actions, CAPAs and resolution to audit findings.
- Support Supplier Quality Engineering to conduct Supplier System and Process Audits in compliance with Nonin’s Supplier Performance and Monitoring goals and objectives.
- Identify and assess suppliers for technical, quality and manufacturing capabilities and opportunities for support business strategies.
- Complete and support supplier process validations to meet applicable FDA and regulatory requirements.
- Required Education & Experience:
- Bachelor Degree in Engineering, Engineering Technology or equivalent technical Degree: or equivalent combination of education and experience.
- Required Knowledge, Skills & Abilities:
- Good interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues
- Self Starter; Highly Organized; Complex Problem-Solving; Strong Analytical Judgment; Technical Detail-Oriented
- Previous experience in working with suppliers and/or subcontractors
- Demonstrated ability to work in a highly regulated environment
- Requires 5 -15% domestic & international travel
- Knowledge of world class quality techniques and implementation
- Prior experience with LED technology
- Experience with FMEA, DOE, SPC
- Experience with Printed Circuit Board Assemblies and electronic components
- Lean manufacturing and continual process improvement experience
- Knowledge of FDA QSR requirements, ISO and other recognized international quality system standards
- Prior experience in an engineering discipline
- Sit, stand, and/or walk for 8 hours/day.
Qualified candidates can mail, e-mail, or fax resume and salary requirements to:
Nonin Medical, Inc.
Attention: HR Department
13700 1st Avenue North
Plymouth, Minnesota 55441-5443