Responsible for design, development, implementation, and analysis of technical products and systems. Produces regulatory and quality system documentation for products and product approvals. Performs engineering design evaluations. Manages interface with third party vendors for testing, transfer to manufacturing, and where outside technical expertise is required. Recommends alterations to development and design to improve quality of products and/or procedures. May require a Masters or PhD in engineering and 3+ years of experience in the field or in a related area. Has knowledge of medical device requirements across multiple markets including USA and EU, and standards commonly used for electrical-medical and sterile medical devices. Generally, relies on instructions and pre-established guidelines to perform the functions of the job, but a certain degree of creativity may be required. Will supervise junior employees and interns. Directly works with Quality to ensure product and process documentation is complete and correct. Inventorship of new product concepts and designs is an important objective of this position. Reports to the President or COO.
Primary job duties and responsibilities include but are not limited to:
- QMS-defined product development and maintenance activities
- Supervision of subordinates and determination of budget and staffing requirements.
- Experimental design, analysis and evaluation
- Engineering Design and support activities
- Prototype design and fabrication
Qualifications include [examples]:
- Advanced degree in engineering or related field or equivalent work experience
- 3+ years in field
- Able to delegate responsibility when needed
- Must have experience working under a certificated quality system
- Understand regulatory requirements for medical devices
- Ability to multi-task, prioritize project goals, and meet timeline goals
- Software experience: Microsoft Office: Word, Excel, PowerPoint, Outlook.
- Preferred technical software: SolidWorks, MATLAB.
- May be familiar with biological wet lab environment, equipment, processes
- May be familiar with machine shop equipment necessary for prototype fabrication
- Position may require use of hazardous chemicals such as organic compounds, solvents, and industrial adhesives; and biohazardous materials, including human tissue and body fluids, such as blood. Handling of human specimens may result in possible blood borne pathogen exposure. Appropriate safety training and equipment will be provided by Company.
- Position may require occasional evening and/or weekend work, as necessary to fulfill manufacturing obligations.
- Adherence to safety standards in the machine shop and the laboratory is mandatory. Safety training and personal protective equipment (PPE) will be provided.
Must be able to stand for up to 4 hours at a time, bend, lift up to 35 lbs. Must be able to manipulate and assemble small parts.
401K, Dental, Life, Medical, Vision
“Environment where you can work independently in a positive environment, creating and executing new ideas is encouraged!”
Interested applicants please contact Samantha at firstname.lastname@example.org.