Sr. Engineer, Quality Product Design

Responsibilities

• Ensure product development and design change initiatives comply with Design Controls and regulations including ISO 13485, ISO 14971, FDA 21 CFR Part 820, and EU MDR.
• Manage the product development life cycle for electromechanical software products to meet quality system requirements.
• Serve as a Subject Matter Expert (SME) for the design and development process, integrating with R&D teams.
• Perform risk analysis and management, implementing mitigation strategies and managing risk files throughout the product lifecycle.
• Develop and implement quality assurance plans, protocols, and standards.
• Support design verification and validation activities, including protocol development, execution, and report generation.
• Maintain Design History Files (DHF) by providing input on design control documentation based on User Requirements.
• Participate in design reviews, test method validations, risk assessments, and code reviews.
• Support Health and Hazard Evaluation processes and regulatory submissions.
• Conduct periodic audits of projects against SOPs and prepare for internal and external inspections.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Science, or a related field.
• Minimum of 5 years of related experience in New Product Development and/or Sustaining Engineering.
• Experience in the medical device industry or other highly regulated fields (e.g., biotech, pharma, aerospace, or automotive).
• Strong proficiency in quality tools and methodologies, such as FMEA and Six Sigma.
• Demonstrated knowledge and application of ISO 14971 and ISO 13485 standards.
• Excellent analytical, problem-solving, and communication skills.
• Proficiency in Microsoft Office Suite.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or ASQ Certified Reliability Engineer (CRE).
• Six Sigma Green Belt certification.
• Experience in project management and leadership.

Benefits

• Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off.
• Wellness initiatives and Health Assistance Resources.
• Life Insurance and Disability benefits.
• Parental and Caregiver Leave.
• Tuition Reimbursement.

About the Company

Datascope Corp. (part of Getinge) provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. We exist to make life-saving technology accessible for more people through innovation in intensive care, cardiovascular procedures, and operating rooms.