Process Development Engineer
RevBio, Inc. Lowell, MA
- Posted: over a month ago
- $75,000 to $115,000 Yearly
- Benefits: life insurance, medical, vision, 401k, dental,
The individual filling this position will actively interface with Manufacturing, Quality, and Engineering teams to develop or update processes needed to manufacture medical device products. This individual will develop concepts, processes, drawings, and prototypes for existing as well as new products. This individual will create, execute, analyze, and report findings to support current manufacturing methods or initiate alternate processes which show improvement in quality or other metrics per design specifications. The individual will have an active role in manufacturing products per (SOP) and document all work per Quality System requirements. The individual will also work with current vendors to build prototypes and/or testing models, and may also interface with other outside resources, as necessary. This individual will develop plans to scale equipment from Lab environment to a facility that meets company needs and is compliant to current ISO/cGMP standards and regulations.
Essential Duties and Responsibilities:
- Support the process development of medical devices following the appropriate standards as per Federal Drug Administration’s Design Controls 820.30 and appropriate international standards (i.e. ISO 13485:2016 Section 7.5.6);
- Develop and communicate project plans, support team communications, perform activities and tasks as allocated, and promote team collaboration;
- Develop and establish process and equipment specifications based on research and development project requirements;
- Develop prototypes, test protocols and test fixtures that conform to the applicable standards and the intended uses to support manufacturing processes;
- Evaluate the performance and associated risks of such devices and related manufacturing processes and implement mitigation activities thereof;
- Work with project teams and Quality department to document any non-conforming records (NCRs) and implement any corrective or preventative actions (CAPAs);
- Interface with R&D engineers, surgeons, customers, vendors, contractors, investors, and other internal and external constituents as needed;
- Support the development of Design of Experiments (DOE) for manufacturing processes;
- Develop, write, revise, and review Standard Operating Procedures (SOPs), or other required documentation (e.g., IQ/OQ/PQ) for current and future products and equipment;
- Perform all planning and documentation activities within company Quality System and where necessary the enterprise resource planning (ERP) software;
- Support manufacturing and facility equipment calibrations and preventative maintenance programs;
- Prepare and support project design reviews;
- Keep accurate notes using company supplied Lab Notebook that is audited regularly;
- Work with Engineering and executive team to understand each projects Manufacturing forecasts to aid in design and set-up of a facility that is aligned with company needs for continuous improvements;
- Think creatively, problem solve, develop innovative solutions based on sound engineering skills and statistical analysis;
- Travel to customers, vendors, and other locations (may require 10-20%), including potential international locations; and perform other tasks as may be required from time to time.
Essential Education, Skills, Environment Education and Work Experience:
- Bachelor’s Degree in Engineering Required (Mechanical, Material Science, Process, or Chemical preferred); Master’s Degree Preferred;
- 3+ years (Bachelor’s) or 2+ years (Master’s) of experience in product or process development; Medical Device or Biotech Industry experience is preferred;
- 2+ experience with medical device mechanical, physical, and packaging test method development, characterization, and verification activities applicable to biomaterials along with applicable sterilization validation procedures;
- Working knowledge of CAD systems (i.e. SolidWorks) experience;
- Experience with ceramics manufacturing, powder manufacturing, and sizing processes;
- 2+ years of experience in design of biomaterials and related applications;
- Proficiency in understanding and application of design controls, development and manufacturing processes, applying state of the art technologies, including statistics;
- Proficiency in developing Design of Experiments;
- Proficiency in using Statistical Analysis Software (e.g., Mini Tab);
- Working knowledge of V&V processes of equipment and related processes (i.e. IQ/OQ/PV/SV).
Specialized Knowledge and Skills:
- The ability to be part of a multi-discipline team in developing medical products and processes;
- The ability to support project timelines independently or within a project team;
- The ability to maintain design control documentation and project files and work within a budget;
- The ability to develop and perform product testing to include mechanical and physical testing;
- The internal motivation and ability to assist driving a project and gain support from various required resources from within and outside of the company;
- The ability to build positive relationships inside and outside the Company, and to effectively communicate project status that might affect related research and development work for other programs;
- The willingness to do “whatever it takes” to help a start-up business “get off the ground” and assist in all necessary areas to achieve success.
RevBio, Inc.Why Work Here?
A great opportunity for growth with an innovative company that is transforming how orthopaedic and dental procedures will be conducted
RevBio, Inc., is a medical device company engaged in the development and commercialization of a patented, synthetic, injectable, self-setting, and osteoconductive bone adhesive biomaterial called Tetranite®. The company is initially developing this technology for use in the dental and cranial market. However, the company is also working to develop adhesive applications for the broader orthopaedics market and additional applications in the animal health market.
600 Suffolk Street (c/o M2D2)Lowell, MA