Join an innovative company focusing on neuromodulation technology for conditions like epilepsy and sleep apnea. This highly collaborative role involves both hands-on involvement in software and firmware development for product and manufacturing test systems. As a vital part of the development team, you will offer strategic technical guidance and leadership, ensuring compliance with crucial industry regulations and quality standards.
Key Responsibilities:
- Provide technical leadership in the software/firmware product development teams with a focus on risk management, design controls, and quality assurance.
- Oversee the change management process for development projects, ensuring careful handling of all modifications and defect resolutions.
- Engage in comprehensive code reviews, offering technical insights that enhance software quality.
- Investigate software/firmware issues and nonconformities, leading root cause analyses and corrective actions.
- Maintain risk management documentation and ensure compliance throughout the product lifecycle.
- Support regulatory audit processes, coordinating relevant activities and serving as a subject matter expert.
Experience & Competencies:
- Substantial experience in software or firmware development specific to the medical device sector, with robust knowledge of IEC 62304.
- Proven ability to build effective, collaborative relationships with internal stakeholders, notably in R&D, Clinical, Regulatory Affairs, and Operations.
- Strong leadership and communication skills, with demonstrated ability to influence and guide cross-functional teams.
- Familiarity with industry regulations including ISO 13485 and 21 CFR Part 820, and the ability to navigate them effectively.
Qualifications:
- Bachelor's degree in Computer Engineering, Computer Science, or Electrical Engineering with relevant software development experience; advanced degrees or certifications are a bonus.
- A track record showing sustained performance over at least 5 years, particularly related to implantable medical devices.
- Strong presentation and procedural skills for participation in audits and regulatory inspections.
This is a fully remote position offering the opportunity to contribute significantly to pioneering medical device solutions.