- Works at a Senior Engineer level as a technical expert and electronic systems engineer of complex medical system technologies
- Assists in developing strategies, timelines and budgets to meet the corporate goals and translates those into technical goals and timelines for the engineering team
- Helps formulate and plan engineering programs and leads internal project staff dictated by project and company requirements in a dynamic multitasking environment
- Participates in the selection of outside consultants and contractors for device related programs and projects and provides technical oversight, guidance and approvals on projects using those resources
- Coordinates external and internal project personnel to specific phases or aspects of programs
- Reviews product design for compliance with engineering principles, IEC Standards, company standards, design for manufacture and Test and related specifications from a senior technical perspective
- May be called upon as engineering liaison for pre-clinical research as required for current and future devices. May co-author pre-clinical protocols for specific engineering research
- Provides technical leadership and mentoring and leads activities concerned with technical developments, scheduling, and resolving engineering design and test problems
- Evaluates and approves design changes, specifications, and drawing releases
- Controls expenditures within limitations of project budget
- Prepares interim and completion project reports as well as working with Quality to ensure compliance to FDA design controls and IEC medical standards
- This position reports to the Senior VP Engineering of Kona Medical, Inc.
Duties & Responsibilities
- Interface with clinicians and others on product development and device research programs or technologies, when called upon to do so
- Manages outside consultants and contractors as well as appropriate internal resources for the successful design and clinical production of focused ultrasound system.
- Assists in budget planning, reporting and resolution of budget issues
- Technical resource and mentor to engineering group and rest of company with respect to current and future medical devices
- Outline and direct engineering verification and confidence studies and tests and author the results
- Provide senior level technical input during the research and design of focused ultrasound technology devices
- May co-author Product Specifications
- Actively pursue intellectual property and examine where new concepts can be converted into patent applications.
- Works under very general direction. Independently plans work and determines and develops approach to solution.
- Other duties as assigned
Required Skills, Experience & Knowledge
- Bachelor’s degree in Electrical Engineering or Bioengineering or a related field required
- 15+ years of experience; experience working with high power systems (including ultrasound) preferred
- Experience in Biology or other life sciences strongly preferred
- Understanding of Design Controls, GMP and Safety Agency regulations
- Possess good working knowledge of lab equipment and research practices a must
- Highly organized with good written and oral presentation skills specifically schedule tools
- Demonstrable experience with the transfer of design into manufacturing
- Ability to work independently and time manage in a highly dynamic environment
- Strong written and verbal communication skills required. Able to communicate effectively with other team members in all departments
Interested candidates are encouraged to apply by sending a resume and/or a cover letter to email@example.com for consideration. Kona Medical is an equal opportunity employer and supports diversity in the workplace.
Kona Medical is a venture-funded medical device company focused on developing game-changing technology for noninvasively treating hypertension. Based in Bellevue, WA, the company comprises a multidisciplinary team of seasoned, highly motivated professionals committed to establishing a world-class product.