Design Assurance – Process Development Manager
Arjo
full-time
Posted on:
Location Type: Hybrid
Location: Malmö • 🇨🇦 Canada
Visit company websiteJob Level
SeniorLead
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
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