Job Description
We are currently looking for a Director or Sr. Manager of Systems Engineering (depending on experience) interested in developing an electrosurgical tool used for transseptal procedures in a fast-paced startup environment. This is a full time on-site position and will require reporting to our office located in Solana Beach, CA. This person will oversee the entire lifecycle from product development to launch and sustaining support while working closely with the company’s internal and external development and manufacturing teams. We are looking for a leader who will be hands-on serving as an individual contributor.
Roles & Responsibilities
- Technical lead for various elements of an electrosurgical system which may include the RF generator, one-time use devices, and/or system accessories through all stages of the product lifecycle.
- Review existing or develop de novo project schedules to identify strategies to de risk timelines as well as to compress timelines to meet company objectives.Interface closely with suppliers including third-party development companies and contract manufacturers on a daily basis to review project status and help eliminate technical hurdles.
- Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions
- Manage 60601 and other electrical safety and EMC, MRI safety, and radio regulation (FCC, RED, etc.) compliance activities.
- Test method development for both characterization testing and verification/validation testing.
- Support of preclinical and clinical testing.
- Strong verbal, written, and cross-functional communications skills.
- Ability to work both independently and in project team settings.
- Collaborate with senior leadership, sales and marketing to develop launch plans.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
Qualifications & Core Competencies
- Bachelor's Degree in ME, EE or a related discipline.
- Minimum 8 years in design/engineering for medical device development and/or manufacturing.
- Preferred: Advanced degree in an engineering discipline.
- Preferred: Experience in class II/III medical device and capital equipment development.
- Preferred: Experience in a startup environment.
Skills & Experience
- Experience with full life-cycle engineering, from concept (prototyping) to production transfer, and scale-up, for an FDA-regulated Class II/III medical devices following design controls best practices.
- Must have prior experience with electromechanical systems / medical capital equipment.
- Electrical or systems engineering background preferred.
- Ability to influence others and deliver effective communication in a dynamic environment.
- High level of independence and ability to self-manage multiple competing priorities.
- Experience scheduling projects using tools like MS Project and building budgets. PMP certification preferred
Location:
- Hybrid/Onsite: Solana Beach, CA
- Flexible/remote arrangements may be discussed on an individual basis
What we offer:
- Competitive pay (salary, bonus, and potential stock options)
- Paid time off (PTO)
