A. Purpose and Scope
The Senior Product Development/Design Engineer is responsible for engineering and designing medical products and surgical instruments and providing engineering leadership within the department. This person will work closely with the Director of Engineering. This position includes interfacing with clients including; project status meetings, product development project planning, tracking and reporting. Working with other internal technical teams as a project lead is a key responsibility, including clinicians, design engineers, industrial designers, consultants, vendors, quality engineers and other support personnel, as needed. The Senior Product Development/Design Engineer should have significant experience in the development of products for the medical device/healthcare industry. This person should have knowledge of creative concept development, clinical issues, prototype experience, analytical ability, materials and design for manufacturing (DFM).
- 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
C. Organization Relationships
The Senior Product Development/Design Engineer reports directly to the Director of Engineering 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 & Training
- 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
- Demonstrated aptitude for creative, “out of the box” thinking, and translating customer needs into product ideas
- Strong mechanical and problem solving abilities
- Demonstrated 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 Requirements
- 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 / elastomer 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.
- Experience and working knowledge of Synectic quality system
Employees are one of the Company’s most valuable assets, and Synectic, a Mack subsidiary, is committed to honoring their contributions through competitive compensation packages, diverse career paths, advancement opportunities and by nurturing a team-oriented, engaging work environment. This position is located in beautiful Woodbridge, Conn., with an unparalleled quality of life.
If interested, call 203.877.8488 x38 today to learn more about employment packages offered, or please complete Mack’s on-line application form (see link below), or send hard copies of your resume, compensation expectations and a letter of introduction to:
Synectic Medical Product Development
11 Lunar Drive
Woodbridge, CT 06525
Attn: Adam Lehman
Resumes accepted from qualified applicants only.