Senior Design Assurance Engineer - Saint Paul, United States - Cypress HCM

Cypress HCM Saint Paul, United States

2 weeks ago

Description

Job Description

Job Description
Senior Design Assurance Engineer
Responsibilities:

Core Team member of medical device development project teams to ensure compliance to Design Controls requirements.
Responsible for quality activities and deliverables on the cross-functional development team.
Responsible for strategic quality planning activities on the project, including PMS planning.
Partners with R&D to ensure proper controls are established at the right level to meet or exceed internal and external requirements.
Partners with QE to ensure process risks are appropriately estimated and process controls are sufficient
Cross-functional leader for completion of Risk Management deliverables.
Partners with Regulatory development project team members to summarize or generate information to be supplied to Regulatory Agencies
Utilizes problem solving methodologies to lead failure investigation activities to ensure root cause is identified and proper controls are established.
Leads design verification, design validation, usability and test method validation activities for new product development to meet or exceed internal and external requirements.
Responsible for comprehensive and robust change impact assessments for engineering changes
Coaches and mentors product development team on Design Control and Risk Management activities.
Drives consistent quality engineering practices among DA team members through collaboration and QMS improvements
Responsible for impact assessment and integration of Quality System changes into project execution.
Ensures quality system compliance during development and primary development team contact for audits.
Surfaces Quality System issues/gaps to appropriate organization level

Qualifications:

BS or advanced degree in engineering or related discipline
5+ years overall medical device experience
5+ years experience in quality assurance or engineering function
Expert knowledge of Design Control and Risk Management
Knowledge of Problem Solving methodologies and approaches
Experience with Quality Systems as outlined in CFR820/ ISO13485
Experience with leading CAPA investigations and developing effective corrective actions that utilize a risk based approach
Demonstrated technical expertise and leadership in quality
Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
Demonstrated use of Quality tools and methodologies
Practical knowledge of applied statistics, including statistical analysis tools (Minitab, JMP, etc.)
High attention to detail, organization and accuracyoffers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.

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