Design Assurance – Process Development Manager
Arjo
full-time
Posted on:
Location Type: Hybrid
Location: Malmö • Canada
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About the role
- 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.
Requirements
- 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.
- Excellent communication skills and stakeholder engagement abilities across global and cross-functional teams.
- Fluent in English; additional languages are a plus.
- Ability to travel internationally as needed to support business objectives.
Benefits
- Work in a highly engaged and flexible work environment, including hybrid (remote and office) work arrangements.
- Recognize and value our global employees.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Product DevelopmentEngineering processesDesign AssuranceSystems EngineeringRegulatory requirementsQuality requirementsProcess documentationStandard operating procedures (SOP)Project managementContinuous improvement
Soft Skills
Strategic thinkingAnalytical skillsProblem-solving skillsAutonomyLeadershipInfluencing skillsCommunication skillsStakeholder engagementCollaborationTraining development