Our Client is a rapidly growing medical device company with a proven track record of successfully developing world-class unique product offerings specializing in surgical devices and wound care healing solutions.
Essential Duties and Responsibilities
- Provide manufacturing engineering support
- Analyze and improve existing processes and products, including updating documentation.,
- Produce detailed designs and/or CAD drawings, acting as technical expert on products and processes.,
- Test products and processes and evaluate results to identify problems and estimate cost of resolutions.,
- Define quality control criteria and safety guidelines.,
- Design, develop, and test processes for producing prototypes and long-term production of products.
- This job will be split between office and manufacturing floor environments, with occasional travel to vendors.
- Work with computer and office equipment, electro-mechanical test equipment, and occasional lifting of items weighing approximately 20 lbs.
Position Type and Expected Hours of Work
- This is a full-time, salaried position. Some evenings & weekends may be required
- Approximately 2-10% travel by air or car required.
- Bachelor of Science degree in Mechanical Engineering, Industrial Engineering, or similar with focus in Manufacturing required, Master’s Degree preferred.
- Experience with packaging and validation of sterile, single-use disposable components
- Minimum 5 years experience (desired) with machined components including:
- CNC Turned Metal Components, lathe and Swiss screw machine
- CNC Milled Metal Components
- Experience with Process Validation / Qualification, PFMEA
- Experience with complex electromechanical assemblies including development of work instructions, and troubleshooting of devices and processes.
- Training of production personnel
Important Skills & Attributes
- Must be a self-starter, capable of completing complex initiatives with minimal supervision
- Excellent written and verbal communication skills
- Proven track record of providing manufacturing support within an FDA and ISO regulatory environment associated with Medical Devices preferred, experience with other highly regulated environments such as military also acceptable.
Contract Specialties Group is an Equal Opportunity Employer. We consider applicants without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, or membership in any other group protected by federal, state or local law.
Job ID: 17296