Associate Project Engineer
Location: Bedford, MA, Franklin, MA
Summary of Primary Responsibilities:
This position is responsible for providing general support of R&D on various existing and new product development projects. This technical role will support R&D scientists and engineers while working closely with Operations, Manufacturing Engineering, Quality, and Regulatory executing activities associated with design control and product launch.
- Works with various departments of the organization including Engineering, Marketing, Operations, and Quality & Regulatory for effective communication and input for existing and new product development projects.
- Supports EU MDR efforts for R&D including design control, biocompatibility and risk management.
- Participates in / manages inhouse or outside testing necessary to fulfill regulatory and design control requirements, including packaging and sterilization validations, component inspections etc.
- Contributes to Design History Files with necessary inputs ensuring design control documentation is complete, accurate and in compliance with FDA and EU Regulations.
- Interfaces with Contract Manufacturers and suppliers to ensure product development issues are resolved under established timelines.
- Records experiments in an organized laboratory notebook and generates necessary technical reports and documentation.
Works on problems of diverse and moderate scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting method and techniques for obtaining solutions. Requires knowledge of FDA, ISO, and other regulatory guidelines related to the manufacturing of medical devices.
No direct reports. Has responsibility to represent R&D in diverse teams as part of the implementation of projects.
Experience, Knowledge and Skills Required:
- Requires a Bachelor’s degree in Engineering or related discipline and demonstrated working knowledge of scientific principles;
- Working knowledge of ISO 14971 Risk Management for Medical Devices and ISO 10993 Biological Evaluation of Medical Devices;
- Working knowledge of cGMPs, QSRs, MDDs and MDRs;
- Familiar with FDA, ISO 13485, MDSAP, TGA, ENVISA and other regulatory agency regulations.
- Familiarity with the principles of Design Control;
- Strong writing and presentation skills.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.