Design Quality Engineer III

Collabera; Boulder (CO); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Paid vacations

401K retirement savings plan

Medical, Dental and Vision insurance

Job summary

A leading IT staffing firm in Boulder is looking for a Software Quality Engineer to design and deliver innovations in medical devices. The role involves implementing regulatory practices, mentoring teams, and ensuring software quality for safety and efficacy. Key qualifications include experience with FDA regulations, Agile development, and strong communication skills. Join a dynamic team offering comprehensive benefits and professional growth opportunities.

Qualifications

• Working knowledge of FDA Quality System Regulation, ISO 13485, and Medical Device Directive.
• Experience in Agile software development techniques and IEC 62304 requirements.
• Good verbal and written communication skills.

Responsibilities

• Design and deliver medical device breakthroughs impacting patient lives.
• Ensure software development follows good design practices and regulatory requirements.
• Provide leadership and training for computerized system validation.

Skills

FDA Quality System Regulation

ISO 13485

Product Risk Assessment

Agile software development

C and C++

Communication skills

Job description

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.

Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

Job Description

Design and deliver the medical device and supplies breakthroughs that make a difference in the lives of millions of patients. Responsible for ensuring that software used in the development, manufacturing and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. Provide leadership, oversight and training to division manufacturing plants for computerized system validation. Mentor design teams on quality systems and requirements.

Qualifications

• Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
• Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and knowledge of how these are applied in the software development lifecycle
• Experience in Agile software development techniques and IEC 62304 requirements, versed in guidance documents such as TIR-45, IEC TR 80002-1 and Cyber security guidance from FDA
• Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products
• Experience in risk evaluation techniques, such as Product Risk Assessment and FMEA including software risk assessment and software FMEA
• Familiar with reliability analysis and test methods, including software reliability modeling
• Working knowledge of C and C++
• Good verbal (including presentation) and written communication skills
• Ability to effectively work on project teams

Additional Information

To get further details or to schedule an interview please contact: