Product Realization Engineer

Job Description:

A. About Synectic

Synectic product development is a full-service engineering company focused on product design, research, prototyping, and manufacturing of medical devices and consumer products. We are located in Woodbridge, Connecticut.

Our approach to engineering stems from “synectics”: a problem-solving technique which seeks to promote creative thinking, typically among small groups of people of diverse expertise. This collaborative approach to product development included design for manufacturing, simplifying components and process, using standard materials, leveraging critical dimensions to promote quality and custom making fixtures/equipment/tools when needed.

Synectic’s engineering staff has decades of experience in innovative design and manufacturing; Synectic has over one hundred patents. Our facilities include a full machine shop, prototyping centers, in-vitro tissue lab, and manufacturing clean room. We are ISO 13485:2016 certified.

Synectic helps a wide range of customers, from large medical device companies to entrepreneurs, bring their medical device concept to production reality. Synectic’s unique approach to low-volume production allows clients to make fully traceable parts for their clinical studies and 510K FDA submission.

B. Purpose and Scope

There is a saying at Synectic: “You shouldn’t design what you can’t build”. Synectic Product Realization program introduces junior engineers to medical device production as a means of gaining experience in design and development.

Candidate will leverage Synectic’s vast engineering resources to ensure that client projects quickly move from final design to production.

The candidate will learn how to apply Design for Manufacturing or DFM to help clients finalize their product designs. The candidate will be well versed in regulatory requirements and Synectic’s QMS. The candidate will support manufacturing development and ensure successful production of client products.

Candidates that are successful in this position are creative, curious, analytical, detail oriented, disciplined, strategics, and great communicators.

C. Responsibilities

Responsibilities include:

• Participate in project brainstorming meetings
• Become an advocate for the Synectic’s Quality Management System and ISO 13485 processes
• Perform engineering activities, including, ensuring customer requirements are met, maintaining compliance with quality system requirements, and participating in project status meetings
• Interface with clients regarding project status
• Participate in material, component and device assessment and selection for devices and implants
• Support production, from initial manufacturing development through to clinical sample production.
• Develop and communicate to customers results using Microsoft PowerPoint or word, as applicable
• Capable of troubleshooting and debugging prototypes against specification documents
• Manage assembly technicians.
• Aid in the assembly of small volume production runs. Including assembly, incoming inspection, maintenance, etc.
• Perform improvement analysis or troubleshooting on current and new manufacturing processes.
• Process paperwork for manufacturing. Including keeping track of inventory, receiving, work in process and outgoing (DHR) documentation.
• Perform in line output studies (scrap/good).
• Perform improvement analysis or troubleshooting on current and new manufacturing processes.
• Set up new production process. Design fixtures, equipment and tools as needed.
• Procure (order) parts.
• Learn and eventually help draft ISO 13485 documentation such as risk management, manufacturing documentation, quality plans and process documentation.
• Learn and eventually become an expert at DFM, including dimensioning drawings, understanding manufacturing processes and impact on design, becoming metrology expert, etc.
• Draft QMS documentation.
• Capable of developing and executing clinical and engineering testing protocols

Job Requirements:

A. Education & Training

• A minimum of a four year college degree in engineering or science, or equivalent experience, is required. (Example: Mechanical Engineering, Materials Engineering, Biomedical Engineering, Industrial Engineering…)
• 1-3 years of industry experience required
• Medical Device industry background, including GMP

B. Soft Skills

• Strong mechanical and problem solving abilities
• Leadership ability
• Strong listening, verbal, and written communication skills; including protocol & report writing. Adept at communicating with both technical and non-technical people.
• Demonstrated aptitude for creative, “out of the box” thinking.

C. Technical Requirements

• Skilled at thinking strategically, innovating, and applying technical knowledge to complex problems
• Proficient with 3D CAD applications (SolidWorks preferred)
• Working knowledge of in-house machine shop capabilities and safety procedures (nice to have).
• Solid data analysis, data management, statistics and experimental design skills
• Experience with design, fabrication and validation of simulated use and standardized product performance tests
• Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, PowerPoint and Project
• Basic knowledge of common manufacturing process, including molding, forming, cutting, gluing, fastening, etc.
• Passionate about continuous improvement

If interested, please complete the online application form below. Only resumes from qualified candidates with be considered. Synectic is an Equal Opportunity Employer.