QA/QE Engineer

Job description

**Sr. Software Design Assurance Engineer**
**In this role you**
Will support New Product Development and Sustaining projects within Acute Care Informatics with respect to software, firmware, and hardware from a Software Design Quality Assurance perspective.
**Your role:**
+ Ensures the development, maintenance, and management of comprehensive software quality documentation, ensuring they are accurate, up-to-date, and fully compliant with relevant standards and regulatory requirements throughout the software lifecycle, working under limited supervision.
+ Leading and supporting the development, design verification and hypercare of non-product software assessments and qualification efforts.
+ Leading the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.
+ Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc.

Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software.
+ Serving as SME for Software Design Assurance and collaborate with teams on code review, unit tests, software security analysis, defect and vulnerability triage, creation and review of sBOMs, etc., leading implementation of best practices for software quality processes, Preparing for and participating in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.
**You're the right fit if:**
+ B.S./ M.S. in relevant engineering field (e.g. Biomedical, Computer Science, Software Development, Electrical etc.)
+ 8+ years of experience in Software Quality and/or Software Development in medical device industry with hands on experience with SW Design verification and/or development.
+ Expertise in applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304 and working knowledge with IEC 60601 and other relevant medical device standards
+ Experience with software development lifecycle mythologies including Agile and SAFe, Defect tracking and management tools such a Jira or Clearquest.

Statistical software solutions such as JMP or Minitab,Requirements and Traceability management tool such as JAMA, IBM DOORs etc.
+ You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
**How we work together**
We believe that we are better together than apart.

For our office-based teams, this means working in-person at least 3 days per week.

Onsite roles require full-time presence in the company’s facilities.

Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an office role.
**About Philips**
We are a health technology company.

We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.

Do the work of your life to help improve the lives of others.
+ Learn more about our business.
+ Discover our rich and exciting history.
+ Learn more about our purpose.
+ Learn more about our culture.
**Philips Transparency Details**
The pay range for this position in Cambridge, MA is $97,000 to $140,000 Annually.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

 
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.

Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
**Additional Information**
US work authorization is a precondition of employment.

The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits **will not** be provided for this position.

For this position, you must reside in **or** within commuting distance to Cambridge MA.
#LI-PHI
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran

Required Skill Profession

Other General