Work Flexibility: Hybrid

Position Summary

Partner with cross-functional project teams in New Product Development (NPD) and Engineering Projects during the product development and change control processes to drive quality assurance. Lead risk management activities to ensure the highest level of product and process quality.

Key Responsibilities

Develop quality assurance documentation to support new product development process, sustaining engineering activities and regulatory submissions.Partner with cross-functional project teams to lead product and/or process design and development and change activities.Lead risk management activities for new product development projects and engineering changes.Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.Present risks associated with the product use and track how the design, documentation, and manufacturing process mitigate those issues throughout the development process.Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria. Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, resolve quality problems, etc. Contribute to the completion of final design verification and validation reports.  Develop, review, and approve documents as needed.Support product design transfers to internal and/or external partnersEngage in quality system maintenance by identifying and correcting deficiencies in procedures and practices.Provide support and direction for other Quality Engineers.Analyze and define critical quality attributes for product through risk analysis techniques.Participate in collection of initial market feedback on new products and address early concerns. 
 

Minimum qualifications

BS in a science, engineering or related discipline. MS preferred.4+ years work experience in relevant field.Good written and verbal communication skills in English and Swedish.

Preferred qualifications

Experience with medical device product development lifecycle, including risk management and design/process verification and validation and associated standards.Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. Thorough knowledge and understanding of US and Global Medical Device Regulations.Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.Demonstrated ability to advocate for product excellence and quality.Demonstrated ability to effectively work cross-functionally with other departments, including, Product Development, Regulatory Affairs, and Marketing.

Travel Percentage: 10%