Artificial Intelligence (AI), Biology, Candidate Screening, Change Control, Code Reviews, Code of Federal Regulations, Control Engineering, Cross-Functional, Design Services, Document Control, Document Management, Documentation, External Audit, FDA (Food and Drug Administration), File Maintenance, Genetics, Hazard Analysis, Hospital, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Leadership, Medical Equipment, Presentation/Verbal Skills, Quality Engineering, Quality Management, Record Keeping, Regulations, Risk, Risk Management, Software Administration, Software Design, Software Development, Software Development Lifecycle (SDLC), Software Engineering, Software Specification, Software Validation, Technical Writing, Technical/Engineering Design, Traceability, Validation Plan, Validation Testing, Willing to Travel, Writing Skills
The Quality Design Controls Engineer will serve as the centralized owner of design control execution for software products and software-containing devices. This role involves ensuring the creation and maintenance of software design control evidence for new software releases and changes, working within the existing quality management system (QMS) change control process.
Responsibilities
- Establish and maintain software Design & Development procedures and supporting templates such as Design Plans, Software Requirements Specifications, Design Inputs/Outputs, Design Reviews, V&V plans, and DHF structures.
- Define a scalable DHF/design evidence model suitable for distributed software development, including SaMD classification considerations and SOUP management.
- Assess the impact of software changes on design-control processes within the QMS change control framework.
- Ensure proper linkage of design-change work to controlled documents, records, and training impacts through the QMS change control workflow.
- Collaborate with Regulatory and Quality teams to address potential impacts of software changes on regulatory commitments.
- Integrate risk management activities per ISO, incorporating software hazard analysis and risk controls with verification evidence and traceability.
- Maintain software risk files connected to design decisions, design reviews, and releases.
- Support SaMD classification assessments and document rationale according to MDCG guidance and FDA SaMD frameworks.
- Author and review software verification and validation protocols/reports, ensuring alignment with IEC lifecycle documentation.
- Establish design transfer expectations, linking software development to release readiness.
- Lead cross-functional software design reviews and integrate risk, validation, and design-change documentation.
- Coach internal teams on software design control expectations with practical checklists and templates.
- Serve as SME and key presenter during external audits for software design controls scope.
- Implement and maintain document/record structures for software design evidence in the QMS in partnership with QMS/Doc Control.
Essential Skills
- 3+ years of experience in medical devices/life sciences with a focus on software design controls, V&V, and risk management.
- Proven track record in building and operating software design control frameworks.
- Strong working knowledge of ISO (design & development controls, design changes), IEC software lifecycle requirements, ISO risk management applied to software, FDA SaMD guidance and 21 CFR 820.30 design control expectations, and MDSAP readiness expectations for software.
- Demonstrated ability to lead cross-functional software design reviews and create audit-ready DHFs/RMFs.
- Excellent technical writing and documentation skills.
Additional Skills & Qualifications
- Experience supporting external audits or inspections as a software design controls SME.
- Familiarity with AI/ML-based SaMD documentation requirements.
- ASQ CQE/CQA or IEC training preferred but not required.
Work Environment
This position is 100% remote, requiring occasional travel up to 20%. The role involves collaboration across distributed teams and offers flexibility in working conditions
Job Type & Location
This is a Contract position based out of New York, NY.
Pay and Benefits
The pay range for this position is $50.00 - $60.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Jul 8, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.