Design Assurance & Process Development Manager

Design Assurance & Process Development Manager - Global recruitement

Position: Design Assurance & Process Development Manager

Location: Magog (Canada) or Malmö (Sweden) or Cardiff (United Kingdom) or Poznań (Poland) or Suzhou (China)

Employment Type: Full-time, hybrid work

About the role: The Product Development & Engineering group is a product-centric organization that put its customers first. We focus on creating, improving, and maintaining our products throughout their lifecycle. We are now looking for a new colleague for the PD&E Excellence team, reporting directly to the Director. This is an individual contributor role with no direct people management responsibilities. The “Manager” title reflects accountability for processes, methodologies, and cross-functional alignment.

Responsibilities:

• Act as the driver of the Arjo Product Creation Process, and as the owner of the Design Assurance & Systems Engineering sub-process, ensuring they are robust, compliant, and continuously improved.
• Coordinate the Design Assurance function across PD&E, ensuring teams alignment and securing capabilities.
• Develop, standardize, document and maintain various PD&E processes and procedures (SOP).
• Collaborate with cross-functional teams and lead improvement projects across PD&E, aiming to harmonize workflows, roles & responsibilities and implement best practices.
• Drive communication, build training & support materials and execute training sessions for stakeholders.

Qualifications:

• Bachelor’s degree in Engineering, Technology, or a relevant technical field.
• Excellent knowledge of Product Development and Engineering processes, as well as regulatory and quality requirements applicable to Medical Devices.
• Minimum 7 years of experience in PD&E or related functions, including expert/SME experience.
• Strategic thinking, analytical/problem-solving skills, autonomy.
• Demonstrated ability to lead projects, drive changes and influence through indirect leadership in a global matrix organization.
• Excellent communication skills and stakeholder engagement abilities.
• Fluent in English; additional languages are a plus.
• Ability to travel internationally as needed to support business objectives.