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Manufacturing Engineer - Senior
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Intrinsic Therapeutics
Woburn, MA (In Person)
$137,500 Salary, Full-Time
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Job Description
Intrinsic Therapeutics is the medical device developer and manufacturer of Barricaid®, a spinal implant approved by FDA in 2020 for the treatment of disc herniations. Barricaid® has demonstrated significant benefits through more than a decade of clinical research and use. Studies show that Barricaid® patients benefit from significantly reduced disc reherniations and reoperations - and the associated debilitating pain. Barricaid® is a disruptive technology that has appealed to early adopters and innovators, and is now poised for broader adoption in the near-term. The R&D engineer's responsibilities include undertaking and managing the design control process of new products and processes while ensuring safe and effective products that conform with regulatory standards. To be successful as an R&D engineer you should be able to work effectively within a multi-disciplinary team, have a high level of technical expertise and technical writing skills, and use your organizational skills to guide projects through the design control process.
Primary Duties:
Creation of new products through CAD development and prototype creation Evaluation of prototypes through usability laboratories Coordination and participation of design control process for new instrumentation and implants Completion of verification and validation testing Creation and maintenance of risk analyses documentation (i.e. FMEAs)- Participation in non-conformance evaluations and complaint analyses
- Creation of new process documentation via the company's quality management system and engineering change (ECO) order process
- Consolidation of feedback from field and potential for case support
Critical Knowledge, Skill and Abilities:
- General knowledge of polymer and metal material properties
- Excellent technical writing skills
- Familiarity with document control and operation within a quality management system
- Strong understanding of design control process and risk management
- Ability to handle multiple tasks while maintaining attention to detail and accuracy and working under tight time deadlines.
- Creo / Pro-E, or proficiency in equivalent CAD software
- Engineering drawing creation,
GD&T Experience/Education:
- 2+ years prior experience in a highly regulated industry such as medical, DoD, or aerospace.
- BS in Mechanical Engineering, biomedical engineering, or related degree.
- Technical and hands-on experience with manufacturing equipment such as mills, lathes, and CNC machines.
- Knowledge of FDA QSR, MDD and