Senior Management Team.Reports to the Chief Operating Officer.
Insight Surgeryhelps 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 customimplants, for hospital clients in the UK and US and for leading medical devicemanufacturers.
We are lookingfor a Head of US Engineering to join the Senior Management Team, reportingdirectly to Insight Surgery's Chief Operating Officer.
THE ROLE
Insight Surgery'sengineering function spans the UK and US under a single Quality ManagementSystem. You will lead the US engineering team and, with the Head of UKEngineering, 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 thatframework you have full ownership of engineering in the US region: output,team, working practices, performance, and the Quality Management System as itoperates in your region.
ENGINEERING OUTPUT AND WORKINGPRACTICES
Takeresponsibility for the US team's output, including the design and manufactureof devices, often in a time critical manner. Allocate work week-to-week to makebest use of engineers' time and manufacturing capacity, and set workingpractices that meet demand while quality is maintained and scheduled throughEmbedMed.
- Execution of the QMS across its full scope in region, withaccountability to the Head of QMS function
- Lead representative at regulatory, certification andcustomer 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 andrecords applying to all regions
TEAM, TRAINING AND HIRING
Lead and developthe 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.
QUALITY, REGULATORY AND AUDIT
Fullaccountability 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 andcustomer 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 andrecords applying to all regions
TECHNICAL LEADERSHIP
Lead by exampleon design and manufacture, including hands-on segmentation in the validatedsegmentation 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.
COLLABORATION
Consistencyacross 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 controlroute held by the Head of QMS, and to develop platform and automationcapability once for use across the business.
DEVELOPMENT
Own continuousimprovement of products and services in the US region and on designateddevelopment projects. Work with the COO on technology and product improvement,and with the US Sales team and CCO on standard costing of key engineeringactivities.
EXPERIENCE AND SKILLS
- 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 medicaldevice regulated environment
- Working knowledge of FDA medical device requirements.Familiarity with UK regs is an advantage
- Experience of fronting external regulatory or certificationaudits and owning findings and CAPA to closure
- Knowledge of additive manufacturing processes andtechnology is an advantage
LOCATION
US-based, ideallywithin the Houston area or with good travel links to key facilities in Houstonand Omaha
SALARY AND BENEFITS
- Competitive salary offered based on experience.
- 3% of salary per annum employer retirement contribution
- Membership of Insight Surgery's Company Share Optionsscheme
- Up to 12% of salary per year asa performance bonus
- Membership of the companyhealthcare plan
WORKING HOURS AND HOLIDAYS
- Core working hours are 9AM to 6PM, Monday to Friday
- Work from home if based outside of Houston
- Regular travel to US manufacturing facilities
- Weekly meetings with the senior leadership team
- 18 days per year holiday allowance plus US public holidays