We’re looking for a Process Engineer who can own the journey from design transfer through to routine production with external suppliers. This includes process validation and supplier capability for a highly dynamic and exciting startup company. You’ll work closely with Quality Engineering and Engineering functions to resolve supplier issues through structured NC/CAPA processes and ensure long‑term process robustness for a groundbreaking orthopaedic product that will improve the treatment of Osteoarthritis in the UK and worldwide.The role may be full-time employee or contractor, for the right candidate.
About OSSTEC
OSSTEC is a UK-based orthopaedic MedTech company developing next-generation, cementless knee replacement systems for earlier intervention and active patients. A startup from Imperial College London, the company applies proprietary 3D-printed, bone-mimetic technology to improve fixation, maintain durable bone and simplify surgery.
OSSTEC’s first product, ASCENT™, is a fully 3D-printed partial knee replacement supported by CLARITY, a streamlined instrumentation platform designed for reproducible, cost-efficient procedures and same-day discharge.
OSSTEC is supported by a surgeon team of global clinical leaders spanning the UK and US with high volume procedure throughput. The company is on track for FDA clearance in 2026 alongside a US commercial launch and UK clinical launch, positioning OSSTEC for rapid adoption and strategic acquisition interest in a large and growing orthopaedic market.
We are now seeking to move our established design process through process validation activities and design transfers in preparation for market launch. The next few years will be fast-paced, transformative and exciting.
Job Description
Key Responsibilities
* Lead design transfer from R&D to Suppliers, ensuring design intent is translated into robust, scalable processes.
* Drive DFM/DFAM reviews, tolerance analysis, and manufacturability improvements.
* Working closely with the engineering team to define and approve process flows, PFMEAs, control plans, and inspection strategies.
* Coordinate first article builds, capability studies, and early‑run troubleshooting.
* Act as the primary technical interface for external manufacturers (AM and conventional).
* Review and approve Supplier process changes, validation packages, and quality plans.
* Support Supplier audits, onboarding, and ongoing performance management.
* Ensure suppliers maintain compliance with ISO 13485 and relevant AM standards.
* Liaising with suppliers to construct & review PFMEA documentation
Process Validation
* Own Master Validation Plans for Supplier processes and equipment.
* Review and author IQ/OQ/PQ protocols and reports.
* Oversee Validation of AM processes, including powder control, build parameters, post‑processing, and inspection methods.
* Ensure process capability (Cp/Cpk), repeatability, and reproducibility on an ongoing basis
Supplier Quality Support (NCs, CAPAs, SCARs)
* Collaborate with Quality Engineering to investigate and resolve supplier‑related nonconformances.
* Lead or support root cause analysis using structured tools (5‑Why, Fishbone, DMAIC).
* Define and verify corrective and preventive actions with suppliers.
* Ensure actions are effective, sustainable, and linked back to PFMEAs, control Support supplier‑initiated SCARs and drive closure with clear evidence and documentation.
* Production Scheduling & Operational Readiness
* Once validated, coordinate production scheduling, capacity planning, and supplier readiness.
* Monitor throughput, lead times, and bottlenecks; drive corrective actions where needed.
* Manage engineering changes and controlled rollouts into production.
Inspection & Quality Control
* Develop and maintain inspection plans for AM and conventional components.
* Support CT scanning, porosity analysis, dimensional metrology, and mechanical testing.
* Lead MSA and gauge R&R activities.
* Establish, maintain and own robust incoming goods inspection systems as per QMS
* Identify opportunities to improve yield, scrap, throughput, and cost.
* Apply structured problem‑solving to manufacturing issues across the supply chain.
* Drive supplier‑side improvements in process stability and robustness.
Candidate Profile
Required Experience
* Proven experience in a regulated manufacturing environment (ideally medical devices, though possibly aerospace, automotive etc.).
* Strong background in design transfer, supplier industrialisation, and process validation.
* Demonstrated ability to manage and improve supplier performance.
* Experience in variable and attribute inspection methods such as CMM, gauge go/no go, digital overlays and shadowgraph, and when to deploy them.
* Experience supporting NC/CAPA processes with suppliers.
* It would be a benefit, but not essential, to be familiar with ISO 13485, ISO 14971, and AM standards (ISO/ASTM 529XX).
* Strong understanding of engineering drawings and GD&T is essential, and AM‑specific design considerations would be beneficial.
* Hands‑on experience with design transfer and process control for medical devices.
* Experience with post‑processing of near net shape parts, either forged, cast or AM (machining, HIP, heat treatment, finishing).
* Knowledge of CT or x-ray inspection methods
* Exposure to production planning, capacity modelling, and supplier scheduling.
* Strong statistical analysis skills (SPC, Minitab, JMP).
Personal Attributes
* Systems thinker who thrives at the intersection of engineering, quality, and operations.
* Pragmatic, collaborative, and able to influence both internal teams and external partners.
* Calm, structured, and effective in regulated environments
Start Date
We are looking to hire during Q1 2026 and begin ASAP.
Compensation
* Compensation will be competitive for the industry
* 39 days annual leave per year
* Includes private medical care
* Support from OSSTEC’s personal development & industry mentoring program
Contact Information
Send cover letter and CV to Yann Collins at hiring@osstec.uk
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