Planet Pharma
Senior Design Assurance Engineer I, Software
Senior Design Assurance Engineer I, Software
1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Planet Pharma Senior Design Assurance Engineer I, Software Location:
Burlington, MA Schedule:
Hybrid (Onsite M/W/F) Employment Type:
Full-Time, Exempt Compensation:
$82,500 - $107,200 + 10% bonus + $20,000 RSUs Relocation Assistance:
Available Sponsorship:
Available Reports To:
Sr. Manager, Quality Assurance About the Role We are seeking a
Senior Design Assurance Engineer I, Software
to support full product lifecycle activities related to innovative ocular medical devices. You will focus on design assurance, risk management, and regulatory compliance for software components of medical devices. This includes new development, enhancements, and sustaining engineering efforts. This is a critical role to support increased development work in our software portfolio and is an urgent hire. Key Responsibilities Support software development for medical devices in collaboration with application developers and product teams. Assist in software tool qualification and validation. Review software test protocols and results for design verification and validation. Participate in risk management activities ensuring compliance with ISO 14971, IEC 62304, and ANSI/AAMI SW96. Evaluate and support product design changes. Quality Systems Contribute to engineering change order (ECO) preparation and review. Participate in periodic reviews of quality system procedures. Support CAPA investigations and follow-up tasks. Analyze data trends and help improve quality system processes. May assist in internal audits and compliance checks. Other Duties Collaborate across departments including R&D, Operations, Clinical, and Regulatory to support business objectives. Take on additional responsibilities as needed. Required Qualifications 5+ years
of experience in medical device or a semi-regulated industry ( 8+ preferred ). Strong background in software development and design assurance. In-depth knowledge of: ISO 14971 ,
IEC 62304 ,
ISO 13485 ,
21 CFR Part 820 ,
EU MDD/MDR ,
GDPR ,
IEC 60601 Proficiency in software development tools and languages (e.g.,
C++, C#, Python ). Experience with version control, bug tracking, and automated test tools. Experience in software-related risk assessments, CAPAs, and design reviews in a regulated environment. Education Bachelor’s degree
in science or engineering required. In lieu of a bachelor’s degree, an associate’s degree or upper-level certification in a related field may be accepted. Preferred Attributes Excellent documentation and communication skills. Organized, detail-oriented, and able to manage cross-functional coordination. Demonstrated leadership potential and strategic thinking. Proficient in data entry, ERP systems, and quality/compliance documentation. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering, Science, and Quality Assurance Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Planet Pharma by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Software Design Engineer” roles.
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Senior Design Assurance Engineer I, Software
1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Planet Pharma Senior Design Assurance Engineer I, Software Location:
Burlington, MA Schedule:
Hybrid (Onsite M/W/F) Employment Type:
Full-Time, Exempt Compensation:
$82,500 - $107,200 + 10% bonus + $20,000 RSUs Relocation Assistance:
Available Sponsorship:
Available Reports To:
Sr. Manager, Quality Assurance About the Role We are seeking a
Senior Design Assurance Engineer I, Software
to support full product lifecycle activities related to innovative ocular medical devices. You will focus on design assurance, risk management, and regulatory compliance for software components of medical devices. This includes new development, enhancements, and sustaining engineering efforts. This is a critical role to support increased development work in our software portfolio and is an urgent hire. Key Responsibilities Support software development for medical devices in collaboration with application developers and product teams. Assist in software tool qualification and validation. Review software test protocols and results for design verification and validation. Participate in risk management activities ensuring compliance with ISO 14971, IEC 62304, and ANSI/AAMI SW96. Evaluate and support product design changes. Quality Systems Contribute to engineering change order (ECO) preparation and review. Participate in periodic reviews of quality system procedures. Support CAPA investigations and follow-up tasks. Analyze data trends and help improve quality system processes. May assist in internal audits and compliance checks. Other Duties Collaborate across departments including R&D, Operations, Clinical, and Regulatory to support business objectives. Take on additional responsibilities as needed. Required Qualifications 5+ years
of experience in medical device or a semi-regulated industry ( 8+ preferred ). Strong background in software development and design assurance. In-depth knowledge of: ISO 14971 ,
IEC 62304 ,
ISO 13485 ,
21 CFR Part 820 ,
EU MDD/MDR ,
GDPR ,
IEC 60601 Proficiency in software development tools and languages (e.g.,
C++, C#, Python ). Experience with version control, bug tracking, and automated test tools. Experience in software-related risk assessments, CAPAs, and design reviews in a regulated environment. Education Bachelor’s degree
in science or engineering required. In lieu of a bachelor’s degree, an associate’s degree or upper-level certification in a related field may be accepted. Preferred Attributes Excellent documentation and communication skills. Organized, detail-oriented, and able to manage cross-functional coordination. Demonstrated leadership potential and strategic thinking. Proficient in data entry, ERP systems, and quality/compliance documentation. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering, Science, and Quality Assurance Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Planet Pharma by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Software Design Engineer” roles.
Boston, MA $130,000.00-$180,000.00 6 months ago Boston, MA $125,000.00-$178,000.00 1 month ago Boston, MA $150,000.00-$175,000.00 3 months ago Software Developer – Full stack/back-end
Boston, MA $190,000.00-$220,000.00 2 days ago Boston, MA $100,000.00-$110,000.00 2 weeks ago Boston, MA $125,000.00-$178,000.00 4 months ago Graduate Software Engineer - Up to $110k + Bonus
Boston, MA $108,760.00-$173,800.00 2 weeks ago Frontend Software Developer- React/Redux
Boston, MA $125,000.00-$178,000.00 2 weeks ago Boston, MA $125,000.00-$178,000.00 2 weeks ago Software Engineer: Full-Stack Web Developer
Boston, MA $140,000.00-$215,000.00 2 weeks ago Cambridge, MA $100,000.00-$130,000.00 7 hours ago Waltham, MA $109,800.00-$119,800.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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