What are the responsibilities and job description for the Senior Manufacturing Engineer position at Intrinsic Therapeutics, Inc?
Position Title: Sr. Manufacturing Engineer
Department: Manufacturing
Reports to: VP, R&D and Manufacturing
Date written/revised March 24, 2026
Intrinsic Therapeutics is a medical device company focused on addressing unmet needs in spine surgery. Our device, Barricaid®, is the only FDA-approved bone anchored, annular closure device (2020) and has been proven through more than a decade of clinical research and use. Barricaid reduces disc reherniations and reoperations, helping patients avoid debilitating pain and repeat surgeries.
The Sr. Manufacturing Engineer's responsibilities include maintaining high levels of manufacturing and product quality, managing manufacturing suppliers and process validation efforts, and supporting manufacturing changes within regulatory standards via verification testing and strong technical writing.
To be successful as a Sr. Manufacturing Engineer, the candidate should be a proactive self-starter with ability to prioritize effectively in a dynamic setting. They should be able to work effectively within a multi-disciplinary team, have a high level of technical expertise, and be able to develop and optimize manufacturing processes for maximum efficiency, cost-effectiveness, and quality.
Primary Duties:
- Lead process validation efforts of Intrinsic products.
- Equipment IQOQPQ design and execution.
- Creation and maintenance of process risk analyses documentation (i.e. pFMEAs)
- Participation in non-conformance evaluations including root cause analysis and documentation of disposition
- Participating in Company’s CAPA system
- Coordination of implant and/or surgical instrument manufacturing activities.
- Coordinate with suppliers to source components and communicate design/manufacturing changes
- Preventative Maintenance procedures and execution as required per cycle.
- Creation of new process documentation via the company’s quality management system and engineering change (ECO) order process
- Participation of regulatory submissions pertaining to design and manufacturing changes
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 systemStrong 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:
- 5 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 ISO 9000 regulations.
On the Job Training:
- Quality Manual
- SOP’s related to Intrinsic’s Design Control process; Risk Management; Manufacturing Processes; Purchasing; Inspection; Document Change Control; Traceability; Corrective and Preventive Actions
Quality System support requirements:
- Intrinsic Therapeutics’ Quality Manual & SOP’s.
Physical Demands:
- Duties of this position are generally performed in good working conditions. Occasional exposure to elements such as noise, dust, chemicals, operating machinery, temperature extremes, etc.
- Duties may require extended periods of sitting and sustained visual concentration on a computer monitor, microscope, or on numbers and other detailed data.
· Occasional lifting of items weighing ~20 lbs