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Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Support design quality activities to ensure product development is conducted in compliance with internal procedures, customer requirements, and applicable regulatory standards throughout the product lifecycle.

Under limited supervision and in accordance with all applicable company policies, procedures, and regulatory requirements, this position will include:

Design and Development Support

• Support product development activities in compliance with Design Control requirements and applicable regulations.
• Participate in design reviews and provide quality input throughout the product development lifecycle.
• Review design and development documentation, including requirements, specifications, protocols, reports, and traceability documentation.
• Support maintenance of Design History File (DHF) documentation.

Risk Management

• Participate in risk management activities in accordance with ISO 14971.
• Support the creation and maintenance of risk management documentation.
• Assist cross-functional teams in identifying hazards, assessing risks, and documenting risk control measures.

Software Development Quality

• Support software development activities for Software as a Medical Device (SaMD).
• Participate in reviews of software lifecycle documentation in accordance with IEC 62304.
• Collaborate with software and systems teams to ensure quality and regulatory requirements are incorporated throughout development activities.

Verification and Validation

• Review verification and validation documentation, protocols, and reports.
• Support traceability activities between requirements, risks, verification, and validation deliverables.
• Collaborate with V&V and development teams to ensure objective evidence is generated and documented appropriately.

Cross-Functional Collaboration

• Work closely with R&D, Systems Engineering, Software Development, V&V, Regulatory Affairs, and Quality teams to ensure compliance with applicable quality and regulatory requirements.
• Provide practical quality support while balancing compliance and development needs.
• Promote quality awareness throughout the development organization.

Experience and Education

Required:

• Bachelor's degree in Biomedical Engineering, engineering, physical science, or a related engineering discipline.
• At least 4 years of experience in the medical device industry.
• Experience supporting product development, Design Quality, Verification & Validation (V&V), Systems Engineering, or related engineering activities.
• Experience in multidisciplinary medical device development environments
• Knowledge of ISO 14971 Risk Management principles.
• Familiarity with Design Control requirements and product development processes.
• Working knowledge of IEC 62304 and software development lifecycle processes for medical devices.
• Experience working within a Quality Management System (ISO 13485, FDA QMSR)
• Strong verbal and written communication skills

Preferred:

• Experience with Software Medical Device.
• Experience applying IEC 62304 in a regulated software development environment.
• Certified Quality Engineer (CQE)
• Experience supporting qualification and validation activities, including manufacturing process validation, IQ/OQ/PQ, and Test Method Validation (TMV).
• Experience supporting investigations, assessments, and implementation of quality requirements related to manufacturing processes.

Competencies

• Strong analytical and problem-solving skills.
• Ability to effectively collaborate with multidisciplinary teams.
• Detail-oriented with strong organizational skills.
• Ability to balance compliance requirements with business and development needs.
• Proactive, self-motivated, and eager to learn.
• Passion for product quality, patient safety, and continuous improvement.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.