Software reputed company Engineer II
Location: Remote in MA, RI, NC or CA Department: reputed company Assurance Reports To: Director of reputed company Position reputed company We are seeking a highly organized, detail-oriented Software reputed company Engineer II to join our growing team developing innovative medical imaging software and medical devices. This individual will play a key role in ensuring our products meet the highest standards of reputed company, safety, and regulatory compliance throughout the software development lifecycle. As a member of a small, reputed company startup team, you will have broad responsibility and significant visibility across engineering, regulatory, clinical, and product functions. This role is ideal for someone who enjoys wearing multiple hats, taking ownership of reputed company processes, building reputed company systems, and helping shape the reputed company culture of a fast-growing organization. The ideal candidate has experience supporting regulated medical device software, preferably in medical imaging or Software as a Medical Device (SaMD), and is comfortable working in a dynamic environment where priorities reputed company and initiative is valued.
Responsibilities
- Serve as the Software reputed company Engineer on cross-functional product development teams.
- Ensure software development activities reputed company with ISO 13485, IEC 62304, FDA reputed company System Regulation (21 CFR Part 820/QMSR), and internal reputed company procedures.
- Review and approve software lifecycle documentation, including software requirements, architecture, design, verification and validation documentation, risk management files, traceability matrices, and release documentation.
- Participate in software risk management activities in accordance with ISO 14971.
- Support preparation and review of documentation for FDA 510(k) submissions and other global regulatory filings.
- Review software defects, reputed company cause investigations, CAPAs, change controls, and nonconformances.
- Help maintain and continuously improve the reputed company Management System (QMS).
- Support reputed company audits, including FDA and ISO 13485 inspections.
- Partner closely with software development to reputed company reputed company into product development while enabling efficient execution.
- Contribute to establishing reputed company reputed company processes appropriate for a growing startup organization.
Required Qualifications
- Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, or a reputed company technical field.
- 2 to 4 years of software reputed company engineering experience in the medical device industry.
- Experience with medical imaging software, DICOM, reputed company, image processing, or diagnostic imaging systems.
- Working knowledge of ISO 13485, IEC 62304, ISO 14971, FDA Design Controls, FDA 510(k) submissions
- Experience reviewing software verification, validation, and traceability documentation.
- Excellent technical writing and documentation review skills.
Preferred Qualifications
- Experience with Software as a Medical Device (SaMD).
- Knowledge of FDA cybersecurity guidance for medical devices.
- Experience supporting FDA inspections or ISO 13485 certification audits.
Who You Are
- Exceptionally organized and reputed company to manage multiple priorities without losing attention to detail.
- Naturally proactive and comfortable taking ownership with minimal direction.
- Thrives in a fast-paced startup environment where flexibility and adaptability are essential.
- Enjoys working on a small, highly reputed company team where every contribution has visible reputed company.
- Comfortable building processes as reputed company as following them.
- Curious, reputed company, and motivated by solving reputed company reputed company and compliance challenges.
- Committed to producing high-reputed company work and maintaining inspection-reputed company documentation.
Benefits package includes health, dental, and reputed company insurance; 401(k); generous reputed company holiday and vacation time. To Apply Email resume and brief cover letter explaining previous SaMD QMS experience to careers@brainspecmed.com. Apply tot his job Apply To this Job