Job Title: Senior Product Development/ Design Engineer
The Senior Product Development / Design Engineer is responsible for engineering and designing medical products and surgical instruments and providing engineering leadership within the department.
- Create, experiment with, and evaluate new product concepts
- Lead and Participate in project brainstorming meetings
- Fulfilling Lead Engineer role on projects such as coordinating multi-functional activities (i.e., labs and presentations to clients), providing technical leadership to other members of the team, and acting as the primary customer contact.
- Perform engineering activities, including, ensuring customer requirements are met, prototyping, maintaining compliance with quality system requirements, and participating in project status meetings
- Interface with clients regarding project status
- Perform detailed and systematic trouble shooting of designs; use DOE and Statistical Methods to support decisions
- Assure project proceeds in accordance with the Synectic Design Control System (phases I thru VI).
- Perform according to detailed project timeline (start up to project completion).
- Participate in clinical and engineering test method development and validation
- Perform quality system activities to document design in DHF and DMR; Conduct and document Design reviews, FMEA, Verification, Validation and Manufacturing / Quality planning activities
- Participate in material, component and device assessment and selection for devices and implants
- Participate in process design and optimization, production scale-up and technology transfer, as applicable
- Participate in project summary reports, as applicable
The Senior Product Development / Design Engineer will report directly to the Engineering Manager of the company. The Senior Product Development / Design Engineer works closely with internal and external technical teams such as other engineers, industrial designers, clinicians and vendors.
A. Education and Experience
- A minimum of a four year college degree in engineering or science, or equivalent experience, is required or equivalent experience. Strong listening, verbal and written communication skills required both with technical and non-technical people
- Minimum of five or more years of demonstrated success in product design and development engineering roles with increasing responsibility in an ISO 13485 and/or FDA compliant or similarly design controlled medical device product development environment, specifically including the following experience and qualifications or equivalent experience:
- Success in advancement of multiple new product development projects, from project startup through commercialization
- Aptitude for creative, “out of the box” thinking, and translating customer needs into product ideas
- Strong mechanical and problem solving abilities
- Ability to function independently and effectively within a multi-disciplinary team
- Strong interpersonal communication skills and presentation skills
- Demonstrates strong client centered attitude and maximum flexibility in a rapidly changing environment
- Works to meet project and budget requirements; plans appropriately and informs management to correct deviations
B. Technical Requirement
- Extensive knowledge of medical product development and manufacturing within the mechanical medical device and surgical instrumentation industry
- Skilled at thinking strategically, innovating and applying technical knowledge to complex problems
- Proficient with recent versions of 3D CAD applications (SolidWorks or ProEngineer preferred),
- Working knowledge of in-house machine shop capabilities and safety procedures.
- Knowledge of rapid prototyping techniques, molding and extrusion methods, metal processes and components and common medical device assembly processes
- Familiarity with tissue lab, cadaver lab, and animal lab operations and procedures
- Familiarity with operation of typical mechanical laboratory equipment, as necessary for material, component and device performance evaluation
- Solid data analysis, data management, basic statistics and experimental design skills
- Proficient in problem solving methods, DOE and statistical analysis
- Knowledge of experimental design and test / gauge R & R
- Experience with design, fabrication and validation of simulated use and standardized product performance tests
- Knowledge of polymer / elastomers and metal properties, and common fabrication methods and limitations
- Knowledge of various fabrication and manufacturing methods for materials and their limitations
- Familiarity with observing live human surgical procedures
- Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, PowerPoint and Project
- Basic knowledge of classic stress analysis, Finite Element Analysis and mold flow analysis
- Capable of conducting patent and competitive product research on the internet.
Please submit resumes to: firstname.lastname@example.org