About the Role:The Senior Process / Operations Engineer - Regulated Devices is responsible for overseeing contract manufacturing operations for a Class II FDA-regulated medical device used for capillary blood collection from a patient's upper arm into a collection tube for laboratory diagnostic analysis.
This role serves as the primary operational and technical liaison between internal teams and Contract Manufacturing Organizations (CMOs), ensuring manufacturing processes, product quality, and operational performance meet all regulatory, quality, and business requirements. The senior engineer will work cross-functionally with R&D, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners to support product commercialization, process scalability, validation, and continuous improvement initiatives.
The ideal candidate has strong experience in medical device process engineering, supplier/CMO management, and regulated manufacturing environments with a deep understanding of FDA and ISO quality system requirements.
You Will:Contract Manufacturing Oversight- Serve as the primary technical operations lead for external contract manufacturers and critical suppliers
- Oversee day-to-day manufacturing performance, quality metrics, and operational execution at CMOs
- Ensure manufacturing processes consistently meet product specifications, quality standards, and production targets
- Drive accountability with manufacturing partners regarding timelines, deviations, CAPAs, and continuous improvement initiatives
Process Engineering & Manufacturing Support- Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables
- Partner with R&D during product development and design transfer activities to ensure manufacturability and scalability
- Support process characterization, validation, and verification activities, including: o IQ/OQ/PQ validation
- Process capability studies
- Equipment qualification
- Manufacturing line readiness
- Lead root cause investigations and implementation of corrective and preventive actions (CAPAs) related to manufacturing or process issues
- Monitor process performance and identify opportunities for yield improvement, cost reduction, and operational efficiency
Quality & Regulatory ComplianceEnsure all manufacturing activities comply with:
- FDA Quality System Regulations (21 CFR Part 820)
- ISO 13485
- GMP requirements
- Internal quality system procedures
- Collaborate closely with Quality Assurance to address nonconformances, deviations, change controls, and audit findings
- Support supplier qualification, supplier audits, and ongoing supplier quality management activities
- Ensure manufacturing documentation, Device History Records (DHRs), and validation records are complete and compliant
Cross-Functional Collaboration- Work closely with R&D teams to transition new products from development into commercial manufacturing
- Partner with Supply Chain and Planning teams to support production schedules, inventory management, and demand planning
- Support Regulatory Affairs with manufacturing-related documentation for regulatory submissions and inspections
- Coordinate with Packaging, Sterilization, and Logistics teams to ensure seamless product release and shipment readiness
Operational Excellence- Establish and monitor KPIs related to manufacturing quality, throughput, scrap, and supplier performance
- Drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies
- Support implementation of scalable operational processes as the company grows
- Assist in risk assessments and mitigation activities related to manufacturing and supply continuity
You Have:- Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field)
- 8+ years of experience in process engineering, operations engineering, or manufacturing engineering within the medical device or diagnostics industry
- Experience supporting Class II FDA-regulated medical devices in a GMP manufacturing environment
- Direct experience managing or working closely with Contract Manufacturing Organizations (CMOs)
Strong understanding of:
- Design controls
- Process validation (IQ/OQ/PQ)
- FDA Quality System Regulations (21 CFR Part 820)
- ISO 13485
- CAPA and change control systems
- Experience collaborating with Quality, Regulatory, and R&D teams in a regulated environment
Our Benefits (there are more but here are some highlights):- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- Employee discounts on hims & hers & Apostrophe online products
- 401k benefits with employer matching contribution
- Offsite team retreats
Conditions of Employment:
- This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
- This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
- Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
- Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.
