Research & Development Manager
Organic growth of +10% per year in a small to medium sized company is the definition of exciting. You are constantly testing your own limits as well as the limits of those who work for you. It’s an opportunity to learn every cog in the business wheel and know that at some point, that experience will be invaluable.
What do you need to bring? Electrical Engineering skills, applied in a Medical Device role for at least 8 years as a doer and at least 3 of those need to be in a supervisory/managerial role where you coached others to successful conclusions. Microelectromechanical Systems (MEMS) and Integrated Circuit design in an Analog environment are tools you will use daily. Yes, you also need to be familiar with that laundry list of standards like IEC 60601-1, ISO 13485, ISO 14971 but as importantly, bring your “can-do” attitude.
What is most rare about this opportunity is, as the R&D Manager, your legacy will become the company’s legacy. There’s a team in place and they are hungry. There are products in the pipeline and everyone’s wringing their hands as they wait for the right leadership. And yes, there are customers who know, as good as the current products are, the next gen will be even better. Sound interesting?
- Oversees the company’s proprietary sensor development program and acts as the primary technical contact to internal and external customers
- Works with OEM’s to identify key deliverables and identifies resources needed to meet timelines/expectations
- Strong resource management skills, overseeing, developing and coaching engineers and techs
- Heavily involved in onboarding and training of department members to become effective members of the organization and the R&D team
- Embraces both the hands-on and managerial side of a leadership position as s/he develops new products and works with the team to problem-solve technical issues using tools like PFMEA and DOE
- Describe/defines project requirements (i.e. Microsoft Project) including costs and resources, providing regular updates to the team, the peer group and management
- Within the limits of the QS and RA requirements, ensures compliance with FDA and notified bodies, providing for Design Control and Risk Management systems that are living documents current with the business circumstance
- Serves as the signatory for all R&D Quality or Regulatory documentation, from the DHF to Change Notices
- Ensures that the Design Control and Risk Management systems align to current Regulatory and Notified Body requirements as well as meeting the needs of the current business circumstance
- Interacts with RA/QA to research Regulatory and Safety Standard requirements effecting the company and leads the testing/recording and documenting of results that demonstrate compliance to current standards
- Works directly with clientele to integrate the sensor technology to theirs as well as to develop private labeled devices
- May participate in patent and/or grant application writing
- Leads cross-functional efforts in development and manufacturing transfer to ensure patient safety and product efficacy
- Minimum of a Bachelor’s Degree in Electrical Engineering; Master’s degree preferred
- A minimum of 8 years’ experience in Medical Device R&D developing electrical/electromechanical devices where at least 3 of those are in a Supervisory or Managerial capacity
- Highly knowledgeable in applicable IEC & ISO (e.g. 60601-1, 13485, 14971) standards and applicable regulations both domestic and international
- Demonstrable experience with Design Control and documentation
- Defines, writes protocols, collects data, analyzes and presents the results of experiments that prove efficacy
- Must have strong interpersonal skills, maturity and good judgment; demonstrates a positive can-do attitude