SVP of Product Development to Intelligent Implants Sweden AB

Intelligent Implants is at the forefront of electrotherapeutic devices to treat disease and aid recovery in bone and other tissues.
We pioneer the use of data, engineering, and medicine to bring novel, active and connected medical devices to healthcare. Our integrated devices facilitate treatment for the patient, as well as, decision making for the healthcare professional.

The Position
- Lead the development of the SmartFuse technology system, including the implant (SmartFuse Cage), the wearable (SmartFuse ECaP) and the data system (SmartFuse Cloud, Physician Portal and Patient App) ensuring it moves from prototype & trials, through to a fully functioning, approved & certified system accepted by the medical / healthcare community.

- Put in place the required disciplines and approach to successfully develop a Class III implantable device, including Quality Management System, Validation and Verification Testing to support FIH, getting the system under design controls, establishing design inputs/outputs, etc.

- Recruit and build a highly capable product development team across mechanical, electrical and software disciplines, as well as the necessary support across quality and regulatory.

- Forge a strong partnership with the current R&D team, setting a foundation for a high quality working relationship based on trust and respect.

- Develop effective supply chain partnerships for the group, as well as engagements, where necessary, with external product development partners.

- Support and prepare for engagements with regulatory bodies, setting the company up for maximum success with FDA and CE-mark certification.

- Instil a culture of enthusiasm and excellence around performance, quality, standards and discipline, while ensuring adoption of best practices for a company at this stage of development.

- Design a strong team culture that empowers the group to deliver on its objectives, and is characterised by open communication, the sharing of knowledge, clearing of roadblocks and effective expectation setting.

- Collaborate with senior management in defining the commercial product development plan, ensuring the appropriate strategy and economics for a platform of this type.

Technical Experience
- Leads or has led the development of Class III implantable devices, ideally with exposure to implantable electronics (wireless power & communications) from lab through to market acceptance.

- Technically, and ideally, possesses experience with orthopedic implants, hermetic sealing of implantable electronics, wireless power and communication, wearable medical devices, PEEK and titanium manufacturing, and/or remote monitoring systems.

Leadership
- Possesses strong project leadership skills, with the capability to drive a systematic and planned approach to platform development through the application of established principles and processes.

- Builds strong, high performance, multi-disciplinary teams ideally within start-up environments.

- Mentors and guides, setting clear objectives and influencing outcomes.

- Hands on in style, comfortable with getting involved in all areas of the business with minimal support.

- Organizes and clearly prioritises, unafraid to set an agenda or take the lead.

- Ideally, possesses experience preparing technical/engineering documentation to support FDA regulatory submissions.

- Ideally, possesses experience implementing a quality management system and getting a device under design control.

- Ideally, possesses experience establishing/managing a commercial supply chain .

Likely Background & Personal Characteristics
- Understands & synthesise highly complex issues.

- Guided by data, comfortable with detailed analysis.

- Delivers high impact presentations, and instil confidence and trust amongst multiple stakeholders.

- Hands-on in style, preferring situations in which to get ‘stuck in’.

- Possesses high energy, passion, resilience and commitment to realise goals.

- Mentors and guides where required, setting clear objectives and influencing outcomes.

- Is international in outlook, comfortable with people of different culture.

Please read more about us here: intelligentimplants.co

If you have questions about the position, you are welcome to contact
Recruitment consultant Peder Hansson at the recruitment company Terminalen Executive and Specialist Search via e-mail peder.hansson@terminalen.nu

Note! Terminalen Executive and Specialist Search does not work with staffing services, so you will be directly employed by our client.

Welcome with your application no later than February 15 2022 to www.terminalen.nu/rekryteringar
We are not able to receive applications by e-mail or letter.