Senior Manufacturing Engineer – Manufacturing & New Product Development
Location: Berkeley, CA (on-site)
Experience: 8–12+ Years
Reports To: VP Engineering
Company: Gravitas Medical, Inc.
About Gravitas Medical
Gravitas Medical is a venture-backed medical device company that has developed the Entarik™ System, an FDA-cleared and Breakthrough Device Designated smart enteral feeding platform. Entarik digitizes and personalizes enteral nutrition to eliminate feeding tube “never events,” improve patient safety, and reduce cost of care.
We are entering commercial launch and building the next generation of intelligent enteral devices. We are seeking a senior, hands-on manufacturing engineer to own manufacturing and operations for the current generation while architecting and developing future products.
Role Overview
This is a high-ownership, high-impact role at the intersection of operations, manufacturing, and product innovation.
You will:
- Own contract manufacturing and supply chain execution for the current FDA-cleared product
- Drive COGS reduction and manufacturing optimization
- Develop and execute a roadmap toward U.S. or Central America manufacturing
- Lead supplier redundancy planning and risk mitigation
- Architect and develop next-generation products
This role requires someone equally comfortable in a supplier facility, a design review, a cleanroom, and a startup war room.
Key Responsibilities
🔹 Manufacturing, Contract Manufacturing & Supply Chain Ownership
- Own full lifecycle management of contract manufacturers (CMs)
- Forecast alignment and capacity planning
- Production scheduling and timeline management
- Budget tracking and manufacturing cost oversight
- Yield improvement and process optimization
- Performance tracking (KPIs, scrap, rework, OTIF, quality metrics)
- Lead continuous manufacturing improvements:
- DFM/DFA initiatives
- Tooling and fixture development
- Process robustness and validation
- Root cause investigations and CAPAs
- Drive supply chain optimization to reduce COGS:
- BOM cost reduction initiatives
- Supplier negotiations and cost modeling
- Alternate material sourcing
- Tariff and logistics strategy
🔹 Manufacturing Strategy & Geographic Transition
- Develop and execute redundant contract manufacturer
- CM identification, evaluation, and qualification
- Capital planning and investment modeling
- Risk mitigation and regulatory impact assessment
🔹 Supplier Redundancy & Risk Mitigation
- Qualify and onboard backup suppliers for critical components
- Build dual-source strategy for high-risk components
- Execute verification and validation for alternate suppliers
- Develop supply continuity and risk mitigation frameworks
🔹 Next-Generation Product Development
- Contribute to mechanical architecture for Gen 2 / Gen 3 products
- Rapid prototyping and early bench validation
- Support design verification and validation (DV/EV/TV)
- Drive risk analysis (FMEA) and human factors considerations
- Maintain DHF/DMR documentation
- Support future 510(k) submissions
🔹 Cross-Functional & Strategic Leadership
- Collaborate with firmware, algorithms, regulatory, and clinical teams
- Support sterilization validation, packaging validation, and shelf-life studies
- Define long-term manufacturing and scale strategy
- Mentor future engineering hires as the team grows
Required Qualifications
- B.S. or M.S. in Mechanical Engineering or similar
- 5+ years of medical device experience
- Experience with Class II/III regulated devices
- Strong experience in:
- Manufacturing Operations including Process Validation
- Polymer catheter or tubing systems
- Injection molding and extrusion
- Contract manufacturing oversight
- Supplier qualification and management
- Design controls (21 CFR 820)
- DFM/DFA and process validation
- Proven experience improving yield and reducing COGS
- Proficiency in SolidWorks (or equivalent CAD)
- Comfortable operating in a fast-paced startup environment
Preferred Qualifications
- Experience with sterile disposable devices
- Experience with EO sterilization and ISO 10993 testing
- Experience scaling from pilot to commercial production
- Experience executing manufacturing transfers
- Knowledge of ISO 13485 quality systems
- Startup experience
- Experience with feeding tubes, catheters, or minimally invasive devices
What Success Looks Like (First 12–18 Months)
- Stabilized and optimized current manufacturing operations
- Improved yields and reduced COGS
- Qualified backup supplier for CM-dependent components
- Delivered validated next-generation prototypes
- Positioned company for scalable commercial growth
Why Join Gravitas?
- FDA-cleared, Breakthrough Device Designated platform
- Direct impact on neonatal and critical care safety
- Early commercial stage with significant growth opportunity
- Executive visibility and high ownership
- Opportunity to architect the future of intelligent enteral care
