Risk Manager & Design Control Engineer Jobs

Cerament (Bonesupport)

Location:
Sweden, Lund

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

Come and join BONESUPPORT as Risk Manager & Design Control Engineer. This is an opportunity to apply your expertise in risk management and design control to ensure patient safety and high-quality products.

Job Responsibility:

Plan, lead and implement Risk Management activities according to ISO 14971 across Product Lifecycle Management (PLM) and New Product Development (NPD)
Support Design Controls activities, including labelling
Ensure that products remain in compliance with applicable regulatory requirements and updated standards, guidelines and regulations throughout the lifecycle by updating, reviewing and establishing engineering documents and Standard Operating Procedures (SOPs)
Hold main responsibility for the risk management process in accordance with ISO 14971
Collaborate closely with Quality, Regulatory, Research, Clinical and Operations, as well as external partners

Requirements:

Technical academic background at Bachelor level or higher
At least four years’ relevant experience from the medical device industry
In‑depth knowledge of ISO 14971 and medical device regulations (e.g., EU MDR, FDA Quality System Regulation and ISO 13485)
Hands‑on experience with Design Controls as per FDA and ISO 13485
Strong technical writing and documentation skills
Ability to interpret and implement regulatory changes into existing systems
Collaborative mindset with excellent communication and project management skills
Fluency in English

Nice to have:

Knowledge and experience with Class III implants and combination products
Swedish/Scandinavian language skills

Additional Information:

Job Posted:
December 07, 2025

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Risk Manager & Design Control Engineer