Location: Newtown, PA and Remote
Reports to: SVP Product Development
Reporting to the SVP PD, the Director, Product Development is accountable for enabling Helius Medical, Inc to bring life changing neurological technology solutions to those in need. The Director will be responsible for daily, hands-on, task-level, engagement working side-by-side with the team on all aspects of development, design, as well as sustaining full product life cycle activities. All aspects of the role must be executed with full compliance to applicable medical devices regulations, standards, and related guidance in addition to company policy and procedures.
Essential Duties and Responsibilities:
- Plan, lead, conduct and document Lead, and conduct design and testing of new and current products
- Overseeing design changes as necessary to ensure quality and compliance.
- Plan, lead and guide all engineering aspects throughout the electromedical device lifecycle comprised of mechanical hardware, electronic hardware, firmware, and off device software.
- Design, maintain, and execute fully compliant design control/product realization processes
- Coordinate with commercialization team to foresee/understand critical project activities in order to manage operational issues, resources and tasks to avoid critical path slippage
- Liaison with key external vendor partners in product development and manufacturing, and advise on supply chain and distribution decisions
- Partner with internal groups and external parties to maintain engagement and focus on development commitments and dependencies
- Collaborate, solicit and incorporate inputs from medical affairs, manufacturing, quality, intellectual property, hub services for the design, development and enhancement of products
- Lead in maintenance of existing product lines, coordinating with manufacturing and logistics partners to ensure availability to meet demand
- Lead in developing project scope, estimate and plan development tasks and schedule development milestones as well as develop a project plan per product realization requirements
- Lead all aspects of design control
- Lead risk related to company products and processes
- Lead design meetings to resolve issues and risks; participate in quality and compliance meetings to resolve issues as they arise.
- Lead focus meetings with patients and clinicians to gain insights on the product offering; provide feedback to the R&D team for continuous improvement and device enhancement
- Develop and manage engineering timelines with regular updates to team members across the organization and monitorcritical path issues
- Lead engineering in manufacturing, quality, and regulatory related issues
- Lead in IP technology reviews
Minimum Qualifications & Skills Required:
- Minimum of a BS degree in an engineering field (Biomedical Engineering or Electrical or Preferred), Masters degree highly desired.
- Minimum of 5+ years multidiscipline engineering leadership in the medical devices industry
- Minimum of 5+ years of team and project leadership in the medical devices industry
- Proficient in MS Office, MS Project, and MS Visio with excellent written & verbal communication skills
- Demonstrated knowledge of applicable regulations, standards and guidance including but not limited to ISO 13485 and FDA 21 CFR 820