Risk Management Specialist ||

Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters.  

We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation.  

People – We win as a team.  

Customer – We deliver customer-centric solutions.  

Continuous Learning – We learn and always aim to be better.  

Innovation – We innovate every day.  

Results – Results matter for all of us. 

We’re seeking a Risk Management Specialist II to develop, maintain, and support key activities that ensure the safety and compliance of our products. In this role, you’ll perform autonomous assessments, craft detailed deliverables, and engage with cross-functional teams, including R&D, Quality, Regulatory, Operations, and Commercial. From product development to lifecycle management, you’ll have the opportunity to collaborate with diverse teams and contribute to innovations that make a difference. If you’re passionate about driving excellence and proactive risk management, please apply!

Location: Kalamazoo, MI or Portsmouth, NH

What you will be doing:

• Responsible for Risk management activities, including the incorporation of applicable medical standards.
• Performs and supports Risk Analysis with accordance to the ISO14971:2019.
• Identifies and manages Essential Design Outputs, CTQs and Product Critical Components.
• Assesses risks within new designs proposals and influences developments.
• Follow design control processes while generating and reviewing risk management deliverables e.g. hazards, risk analysis, traceability, risk controls, harms list etc.
• Ensures the implementation of risk control measures is effective and suitable for regulatory submissions.
• Performs Risk/Benefit analysis for existing and newly identified residual risks.
• Participates or lead root cause analyses (e.g., 5Why, Ishikawa etc.) to determine appropriate risk evaluations and risk controls.
• Provides technical direction and best practice guidance to the team members. Independently designs, plans and executes assigned tasks. 
• Partner with R&D Management to implement initiatives supporting strategic direction.
• Adopt an integrated quality and stage gate process to ensure excellence in product development and post-launch support activities.
• Maintain up-to-date knowledge on relevant international standards, recommends and supports changes to engineering practice or project life cycles to ensure compliance (ISO, UL/CSA, CE, QSR, CE, IVDR and other applicable regulatory requirements)
• Manages small design/development sub-projects as needed. Knowledgeable in project management.
• Travel to vendors, customer sites and technical conferences/training possibly up to 10% of time

Skills you will need:

• Bachelor’s degree required in a related Life Sciences or Engineering or significant equivalent experience.
• 3+ years of practical and theoretical experience with Risk Management to in the Medical Device sector (or similar highly regulated environment). 
• Knowledge of 21 CFR 820, 21 CFR 11, 14971:2019  and ISO 13485:2016 associated with the medical device industry.
• Understands and is driven by the industry requirements for IVDR/Medical Devices
• Experience in Product Research and Development projects
• Strong interpersonal skills with a proven ability to collaborate with others in multi-disciplinary team settings, influence decision making, and build group consensus.

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TO ALL RECRUITMENT AGENCIES:  Epredia does not accept unsolicited third-party resumes.
 

Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.