Mechanical Engineering Manager, Medical Device
- Fond du Lac, WI
Headquartered in Atlanta, GA, GF Health Products, Inc. ("Graham-Field") is one of the world’s leading manufacturers and distributors of medical products, with 300 US-based employees, marketing our internationally recognized brands within 84 countries.
GF is seeking a Mechanical Engineering Manager who will work with a cross functional team including Design Engineers, Document Control Engineers, Quality personnel, Product Managers and Corporate Executives to implement products from concept to production throughout the company. This person will serve as the in-house risk management expert as to design and manufacturing of both past and future products. This individual will be the direct manager of all engineering related personnel.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- PRODUCT/DESIGN DEVELOPMENT
- Implement and oversee all engineering design controls as set out in 21 CFR 820.30 and internal COPs.
- In house manufactured products: work with and manage engineering design team to prepare drawings, create bills of material, source or internally prepare production aids including tooling, dies, fixtures and work instructions. Estimate production times, work center costing, staffing requirements, and related costs to provide information for return on investment decisions.
- Outside manufactured products or components: when applicable work with and manage engineering design team to prepare drawings and work with product management and materials management teams to source products to appropriate vendors.
- Work with the quality team to develop and review processes to ensure quality for all new products. Be the final sign off on test specifications, dimensional drawing review, bill of material review and PDD inputs/outputs.
- Communicate with management as to major obstacles/issues involving the launch of a new product.
- RISK MANAGEMENT, DISCREPANT PRODUCT ISSUES, CUSTOMER ISSUES
- Serve as in house expert to evaluate alleged product failures.
- Prepare risk analysis documentation and present the analysis internally and to third parties as required.
- Resolve issues with suppliers and recommend disposition or rework.
- Participate in NCMR meetings.
- Investigate escalated customer issues and advise internal personnel as to the results of the analysis.
- Where needed, interact with customer to present your analysis.
- SUPPLIER EVALUATION
- Work with materials management and quality teams to evaluate current and new suppliers.
- Supervise engineering department.
- Prepare needed documentation as determined with the quality team to ensure compliance with all regulatory requirements.
- Participate as a trainer in quality control and manufacturing employee training programs.
- Participate in internal audits conducted by internal employees and regulatory agencies.
- Work with the quality audit group to assess current procedures/work instructions related to the operations of the company and address deviations/findings/improved processes.
- Travel to company, supplier and customer locations as may be required from time to time. Extensive travel between company manufacturing locations may be required at times.
- Keep abreast of all federal, state and local laws, ordinances, etc… that is relevant to the company’s products and customers.
- Other projects and daily activities as may be assigned from time to time.
- Bachelor’s degree in Mechanical Engineering.
- A minimum of 5 years work experience in manufacturing; medical device or ISO certified manufacturing environment preferred.
- Experience in risk analysis essential.
- Experience in work flow optimization, work measurement, and work efficiencies; recognized process improvement training (Lean, Six Sigma) preferred.
- Excellent interpersonal/communication/problem solving skills (both verbal and written).
- Attention to detail and good analytical skills.
- Good organizational skills and accurate prioritization abilities.
- Strong independent work ethic and ability to manage multiple tasks, individually and as part of a team.
- Ability to lift and move from 10 to 50 pounds.
- Experience working with AutoCAD and Solid Works software.
- Proficient in all MS Office software, Minitab a plus.
To apply for this position please send a cover letter and resume to email@example.com
All qualified applicants will receive consideration for employment without regard to race, color, gender identity or expression, age, religion, intellectual disability, mental disability, physical disability, including but not limited to blindness, unless it is shown that such disability prevents performance of the work involved, medical condition, handicap, national origin, ancestry, sexual orientation, marital status, domestic partnership status, parental status, military status, veteran or military discharge status, source of income or housing status or any other status protected by applicable law.
GF Health Products, Inc. is a drug free workplace
All your information will be kept confidential according to EEO guidelines.