Medical Device Engineer Job in Victor 14564, New York Us
Position Title: Medical Device Engineer
Company: LSI SOLUTIONS®
Job: LSI SOLUTIONS® has an exciting opportunity available for a Medical Device Engineer who is a bright, accomplished team leader with excellent experience in medical device manufacturing. This position will work closely with the entire discovery and engineering team and be responsible for the rollout of new and innovative surgical devices. The right candidate must be self driven, creative thinker and problem solver with a can do attitude.
Company Info: LSI SOLUTIONS®, located in beautiful Victor, New York, is a medical device company dedicated to advancing minimally invasive therapeutics through research, development, manufacturing, and marketing proprietary products.
Job Responsibilities:
- Responsible for the transfer of new projects from the design concept to the manufacturing platform for assigned projects.
- Participate in all phases of design development for assigned product lines.
- Responsible for the transfer of major design changes that affect the product line. Communicate changes to manufacturing personnel. Assure that unique training requirements are met.
- Continuously work to improve manufacturing methods, efficiency and product quality reliability.
- Specify and provide all necessary tools, equipment, and fixtures, and facilities required for assigned product line.
- Oversee verification and validation of new designs.
- Develop and validate processes for manufacturing.
- Qualify suppliers supporting assigned product lines; verify each supplier’s capability and capacity to provide required component quality level at required volume.
- Serve as interface for key suppliers. Provide training and assistance as necessary, with a particular emphasis on plastic and metal formed parts.
- Define and develop assembly methods for assigned product line. Assure that work instructions and drawings are created when necessary.
- Monitor quality reports and field performance of assigned product line, identify trends, investigate problems and ensure proper implementation of corrective actions.
- Support and adhere to the Quality Policy and Quality System procedures.
- Work in dynamic environment with minimal supervision.
- All other duties as assigned.
Recommended Skills:
- Experience in Project Management. Ability to manage projects, people and lead and coordinate cross-functional teams and task forces.
- Expertise in communicating requirements to suppliers and qualifying the supplier’s capability to fulfill those requirements.
- Must be able to work in a dynamic environment with minimal supervision.
- Excellent communication skills (verbal and written). Ability to communicate with all level of the organization including but not limited to medical professionals and surgeons.
- Experience in a regulated industry.
- Strong CAD proficiency (AutoCAD and AUTODESK Inventor preferred). Capable of generating complete design drawing packages that are sufficiently detailed to support fabrication without ambiguity.
- Expertise in aspects of plastics and metal forming from part design for manufacturability to process parameters for injection molding, thermoforming and complex tolerances of metal forming.
- Familiarity with mold design.
- Experience with machining methods and use of machine tools.
- Understanding of Lean Manufacturing principles preferred.
- Experience with electronic change control systems in a regulated environment.
- Experience with “6-sigma” continuous improvement methods and lean manufacturing concepts.
- Experience with Design of Experimentation methodology.
- Exposure to Statistical Process Control theory and application.
Education:
- Bachelor's Degree
Experience:
- 4-6 years experience in manufacturing engineering or technical operations in the medical device industry.
- Substitute two years experience for a Master's Degree in Engineering.
Status: Full Time Employee
Salary: Salary based on experience.
Benefits: Excellent medical, dental, life insurance, vacation and 401(k).
Job Location: Victor, NY.
How to apply:
Please provide your resume (as a PDF or Word file attachment), salary requirements, and a brief cover letter presenting your special qualifications to: Employment@LSISOLUTIONS.com
LSI SOLUTIONS® is a Drug Free Workplace.
Candidates are required to pass a drug test and background check
before beginning employment.