Head of US Engineering

Senior Management Team.

Reports to the Chief Operating Officer.

Insight Surgery helps surgeons plan the most complex surgeries. For the past 9 years we havebeen designing and manufacturing cutting edge patient-specific medical devices,including anatomical models, surgical cutting guides and complex custom implants, for hospital clients in the UK and US and for leading medical device manufacturers.

We are looking for a Head of US Engineering to join the Senior Management Team, reporting directly to Insight Surgery's Chief Operating Officer.

Insight Surgery'sengineering function spans the UK and US under a single Quality Management System. You will lead the US engineering team and, with the Head of UK Engineering, maintain one common approach to the design and manufacture ofpatient-specific devices, so that a device of a given type is planned,designed, reviewed and released the same way wherever it is produced.

Within that framework you have full ownership of engineering in the US region: output,team, working practices, performance, and the Quality Management System as it operates in your region.

Take responsibility for the US team's output, including the design and manufacture of devices, often in a time critical manner. Allocate work week-to-week to makebest use of engineers' time and manufacturing capacity, and set working practices that meet demand while quality is maintained and scheduled through

Embed

Med.

• Execution of the QMS across its full scope in region, withaccountability to the Head of QMS function
• Lead representative at regulatory, certification and customer audits and inspections, including FDA inspection
• Ownership of findings and CAPA arising in the region,through to closure
• Standing member of the Quality Management Review
• Working knowledge of, and access to, all QMS documents and records applying to all regions

Lead and develop the team, monitoring performance quantitatively and setting development goalsthat deliver high standards. Own induction and the Level 1, 2 and 3 progressionprogramme, recording the detail needed for the qualification requirements of theQMS. Lead recruitment and technical evaluation as the team grows, and work withthe Senior Management Team on a suitable engineering organizational structure.

Full accountability for the Quality Management System as it operates in the USregion, under ISO 13485 and FDA Quality Management System Regulation.

• Execution of the QMS across its full scope in region, withaccountability to the Head of QMS function
• Lead representative at regulatory, certification and customer audits and inspections, including FDA inspection
• Ownership of findings and CAPA arising in the region,through to closure
• Standing member of the Quality Management Review
• Working knowledge of, and access to, all QMS documents and records applying to all regions

Lead by exampleon design and manufacture, including hands-on segmentation in the validated segmentation software and free-form design in the validated design software,according to internal QMS procedures. Maintain excellent technical knowledge ofpatient-specific devices, orthopedic surgery and additive manufacturing inorder to mentor the team.

Consistency across the engineering function is a Quality Management System requirement.

Work closely with the Head of UK Engineering to agree shared design methods,job aids, training material and controlled documents, within the change control route held by the Head of QMS, and to develop platform and automation capability once for use across the business.

Own continuous improvement of products and services in the US region and on designated development projects. Work with the COO on technology and product improvement,and with the US Sales team and CCO on standard costing of key engineering activities.

• Engineering degree, bio-medical specialization preferred
• At least 5 years' experience leading a team of engineers ina commercial environment
• Sector specific knowledge of the Orthopedic market,preferably alongside the design of patient-specific surgical devices
• At least 5 years within an ISO 13485 controlled and medical device regulated environment
• Working knowledge of FDA medical device requirements.
  
  Familiarity with UK regs is an advantage
• Experience of fronting external regulatory or certification audits and owning findings and CAPA to closure
• Knowledge of additive manufacturing processes and technology is an advantage

US-based, ideally within the Houston area or with good travel links to key facilities in Houston and Omaha

• Competitive salary offered based on experience.
• 3% of salary per annum employer retirement contribution
• Membership of Insight Surgery's Company Share Options scheme
• Up to 12% of salary per year asa performance bonus
• Membership of the company healthcare plan

• Core working hours are 9AM to 6PM, Monday to Friday
• Work…