The Principal Development Engineer at Resonetics Design and Development Services will be responsible for driving the development of novel medical device technologies from concept through market introduction. They will lead one or more development programs, managing the day-to-day activities of large project teams and providing technical oversight and troubleshooting support where needed. The Principal Development Engineer acts as a liaison with the customer, facilitating a single point of contact and providing proactive project status updates on a regular basis.
- Leads project teams through novel interventional device development while providing technical oversight, budget and timeline management, effective customer communication and mentorship of junior resources.
- Sets direction on core technical strategies. Facilitates collective review of key development threads to establish buy-in and ownership with the customer and project team.
- Coordinates project action items, including managing concurrent development threads. Delegates and manages tasks among internal team members to drive execution of project deliverables and minimize risk.
- Tracks program progress against originally proposed timeline, scope, and budget; communicates and documents changes in scope as needed.
- Understands, tracks and articulates issues / risks / action items; coordinates with internal management to ensure that appropriate resources have been assigned and works with responsible task owners to address action items on a timely basis.
- Serves as the primary contact with external customers on large device development programs. Coordinates and directs customer meetings, visits, and day-to-day communications.
- Plans and communicates effectively to mobilize internal resources around key program goals and milestones. Provides clear and frequent internal communication around project milestones and priorities through documentation of project meetings, customer communications, and decisions as appropriate.
- Proactively communicates escalations around project challenges, gaps, support required and resources needed to proactively address issues before they impede successful delivery of the program.
- Supports preparation of proposals, including definition of scope, timeline and budget.
- Interacts with senior leadership on complex matters requiring additional support and/or coordination between sites.
- Ensures diligent adherence to Design Control procedures (i.e., guidance of DV test planning) and works with Quality Assurance to maintain detailed documentation throughout the product development process.
- Leverages a thorough understanding of the medical device product development lifecycle to inform high-level project decisions.
- A minimum of 7 years’ experience in medical device product design and development.
- Strong project management experience leading cross-functional teams in a technical environment.
- Strong analytical and data-driven approach with proven problem-solving abilities.
- Strong presentation, written, and verbal skills. Ability to communicate with all levels within the organization.
- Solid team leadership, team building, and facilitation skills.
- Demonstrated mediation skills and ability to resolve apparently conflicting requirements through effective communication.
- Ability to facilitate a collaborative working environment for customers and team members.
- Comfort communicating and/or presenting in front of clients and large project teams.
- Ability and willingness to travel.
- Close familiarity with FDA QSR and ISO 13485 medical device regulations.
- Experience in all phases of the medical device product development lifecycle.
- Technical degree in Mechanical or Biomedical Engineering.
- Depth of knowledge in one or more clinical areas.
- SolidWorks proficiency.
- Knowledge of probability and statistics.
- Experience with transfer to production and/or sustained manufacturing of complex medical devices.
- Able to work in an office environment and travel independently.