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Principal Software Engineer
- Actalent (Mahwah, NJ)
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Principal Software Engineer
Work with the engineering team to solidify a new implant and instrument design control and risk management structure, based on a systems engineering approach. Develop architecture documents and use cases to help establish tiering of requirements as well as trace matrixes for design verification and validation.
Help with scoping of the JR implant and instrument portfolio and translation from legacy design controls to this new structure. Implement this structure to work within the Jama requirements software system.
System engineering techniques such as: traceability, architecture, modeling, trade studies, simulation, and budgeting. Systems Engineers are also responsible for ensuring the systems gets integrated and may lead the Verification effort.
Technical Responsibilities:
Under minimal supervision:
• Research, design, develop, modify, and verify medical device systems.
• Translate user needs to system requirements.
• Modify existing system architectures or test designs.
• Create new system architectures or test designs for simple product or features.
• Contribute to design decomposition using, modeling, simulation, budgeting, or mathematical techniques.
• Apply fundamental and some advanced concepts, practices and procedures for problem solving.
• Contribute to Product Risk Management activities.
• Develop system architecture for joint replacement instrumentation design controls and risk management.
• Translate legacy requirements to new requirements in order to facilitate a systems approach and consolidated design controls and risk management.
Business Responsibilities:
• Demonstrate advanced understanding of customer needs and design inputs.
• Demonstrate proficiency with product’s intended use and clinical procedures.
• Learn how the financial models are constructed.
Med Device Compliance:
• Follow fundamental industry standards, design requirements and test strategies which apply to regulatory requirements.
• Independently create or refine engineering documentation, such as the Design History file.
• Follow R&D procedure like design controls and risk management, per the Quality Management System.
General Responsibilities:
• Under minimal supervision, work with all stakeholders to ensure project success.
• Quickly process and assimilate procedures, policies, processes, systems, and technology required.
• Work on complex problems, applying advanced experience and learnings.
• Demonstrate ownership and prioritize work with minimal supervision. Works as key member of the team, collaborating with others and solidifying relationships.
Technical Skills:
• Working knowledge and understanding of requirement and verification practices.
• Working knowledge of Requirements Management Tools.
• Ability to communicate basic plans and technical information to team members.
Preferred Skills /Engineering tools:
• Requirements Management Software, especially Jama.
• Experience with SysML and Model-based Systems Engineering.
• Experience with SysML / MBSE software tools.
• Knowledge of ISO 13485 and ISO 14971.
Certifications:
• INCOSE ASEP certified, or equivalent.
Educational REquirements:
• Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering & 2+ years of work experience.
Job Type & Location
This is a Contract position based out of Mahwah, NJ.
Pay and Benefits
The pay range for this position is $45.00 - $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 onsite position in Mahwah,NJ.
Application Deadline
This position is anticipated to close on Nov 24, 2025.
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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
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