Mansfield, Massachusetts, United States
Job type: fulltime
Job industry: Healthcare & Medical
R&D Engineer - Medical Device Plastics
SUMMARY OF POSITION:
A Senior Research Engineer will perform product sustaining engineering activities on Negative Pressure Wound Therapy products. The key requirement for this position is a solid plastics background. The individual in this position will lead small projects, but will also assume an individual contributor role. The engineer must have the flexibility of skill and temperament to work in product change development. Attention to detail and working knowledge of regulations for the medical device industry are essential. The engineer must be able to work in a team environment and be able to communicate clearly across all disciplines including: Quality Assurance, Regulatory Affairs, Manufacturing, Marketing, and outside design partners and regulatory agencies.
Travel Requirements: possible travel to Miami, FL
- Contribute to the development and maintenance of disposable medical devices.
- Write and review technical specifications
- Conduct technical and design reviews
- Write protocols and reports for various technical aspects including design verifications and validations
- Conduct and/or orchestrate device and component testing
- Conduct product development tasks & documentation required to satisfy design controls and risk management in accordance with established SOPs.
- Provide presentations, reports and schedules as required to manage projects and to communicate status, risks and issues.
- Effectively and thoughtfully incorporate required regulatory medical device standards (FDA, ISO, IEC, EN)
- Construct Design History Files in accordance with SOP's.
- Provide solutions to technical issues and implement using the established Change Development Process
- Work directly with offsite and 3rd party design engineering resources
Education: BS, Plastics, Mechanical or Biomedical engineering
Bachelor's plus a minimum of 5 -10 years relevant medical device experience; or Master's plus a minimum of 5 years relevant medical experience;
- Knowledge of Good Manufacturing Practices (GMP), Quality System Regulations (FDA QSR) and design controls
- Design for Six Sigma techniques and methodologies and knowledge of Statistical Analysis, and Design of Experiments. Working knowledge of Minitab or equivalent statistical analysis tools
- Strong written, verbal, and presentation skills
- MS office tools including Word, Excel, PowerPoint, Project
- Familiarity with medical device safety standards
- Thorough understanding of engineering practices, product safety and root cause analysis.
- Familiarity with component manufacturing processes, such as injection molding, extrusion, bonding and sealing
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice