Principal Systems Engineer leading new product development and ensuring compliance for implantable medical devices. Collaborating on technical leadership and process management for high-quality outcomes.
Responsibilities
Lead, define, and evaluate new product development and existing designs using a systems approach.
Support all project initiatives for implantable devices.
Lead efforts to create and/or modify Standard Operating Procedures.
Drive the architecture, system design, system boundaries, and all associated interfaces.
Ensure adherence to applicable standards such as IEC 60601, ISO 14708, ISO 14971, IEC 62304, and other related AIMD requirements.
Support the product lifecycle from concept through verification, validation, transfer to manufacturing, and post-market support.
Establish and advocate for best practices and continuous improvement to mature Systems Engineering knowledge and processes.
Requirements
Bachelor’s in Electrical Engineering, Software Engineering, or related field.
Master’s degree in related field is preferred.
7+ years of engineering experience.
Active Implantable medical device system experience.
Experience or knowledge of software, analog and digital systems.
Systems level design experience with active implantable medical devices, including those that use external programmers.
Benefits
Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy.
Access to company sponsored wellness programs and mental health resources.
Paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
A competitive 401(k) plan with company match that vest immediately.
Financial planning services to help you secure your future.
Corporate discount programs for goods and services.
Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
A supportive work environment where everyone feels valued, and has a sense of belonging.
Participate in team-building activities, volunteer opportunities, and company-sponsored events.
Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
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