Sr. Design Assurance Engineer - Stop SHips

Hologic•Marlborough, MA

3d•$97,600 - $125,200

About The Position

The Senior Design Engineer - Stop Ships ensures the safety, effectiveness, and compliance of medical devices by applying expertise in design controls, risk management, quality systems, and change management. This experienced professional leads the assessment and resolution of product quality and safety issues, including Stop Ship activities, using sound technical judgment and analytical problem-solving skills. Working independently with minimal supervision, they evaluate complex situations, drive effective solutions, and collaborate with cross-functional teams and senior stakeholders to maintain product quality, regulatory compliance, and patient safety throughout the product lifecycle.

Requirements

Bachelor's Degree (Engineering, Biomedical or related field preferred), May have Master’s Degree, May have PhD
5-8 Years of Experience with a Bachelor's Degree
2-5 Years of Experience with a Bachelor's Degree in a Technical Field
1-3 Years of Experience with a Master’s Degree
0-1 Years of Experience with a PhD
Experienced with FDA-Medical Devices-820 Quality System Regulation, especially Design Control requirements, ISO 13485 Medical Device Quality management System, ISO 14971:2019, Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive, Regulation (EU) 2017/745 (MDR) European Union Medical Device Regulation
Prior experience in medical device or other highly regulated industry
Experienced with Good Laboratory Practices
Experienced with Usability, Reliability, Electrical Safety and Software standards and regulations.
Ability to drive action in accordance with Deming Cycle (PDCA) Principles
Working knowledge of verification and validation requirements for a regulated product
Working knowledge of requirements analysis, including development of testable and measurable specifications
Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution.
Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment.
Strong written, verbal and technical writing communication skills. Fluent English (written and verbal).
Strong presentation skills
Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments
Communication/Active Listening, Collaboration/Team Player, Responsibility/Accountability and Reliability, Organization/Planning/Time Management, Problem Solving/Creativity, Strategic, Analytic/Focus/Critical Thinking, Flexibility and Adaptability

Nice To Haves

Bilingual is beneficial.
ASQ Certified Quality Engineer is desirable.
Six Sigma Certification is desirable.

Responsibilities

Maintains and employs extensive integrated knowledge of assigned products to provide support assuring Medical Device Quality, Compliance and Safety along life cycle from product development to market and post-market follow-up. Significant contributor in activities to assess product performance accuracy and clinical efficacy.
Administrative Responsibilities include attending all meetings (staff, core team, key one-on-one, multifunctional priority setting meetings, sustaining, etc.), reviewing and responding to emails and other messaging platforms.
Responsible for sustaining activities of marketed Medical Devices include facilitating the application of design controls for manufacturing and design changes, implementing improvements for manufacturability, participating or leading business continuity projects (i.e., internalizations, supplier changes and value improvement projects), all while assuring quality, compliance, and safety.
Responsible for Quality Activities include constant refreshing of learning assignments of internal procedures, supporting internal and external audits, supporting NCEs, CAPAs, SSEs, QPLs and other quality figures, and supporting complaint investigation for Post Market Surveillance.
Implementation and maintenance of Risk Management throughout the device product life cycle.
Ensure product and design requirements are properly established, qualified, and met.
Assess change requests of products for impact to design, prioritizing compliance to maximize quality and customer safety.
Support all activities that Design Assurance is Responsible, Accountable, and Consulted for during product development or product transfers (acquisitions) including validation, verification, and clinical preparation where applicable.
Collaborate in multifunctional teams to develop strategies that challenge the medical device design and performance and create objective evidence for quality and safety compliance.
Participate in Test Method Development and Validation.
Maintain accurate records of testing strategies and outcomes.
Conduct Health Risk Assessments when needed for evaluating an on-market product, demonstrating efficient and effective analysis of the situation, including problem definition and impact.
Execute Risk Assessments in support of both on-market devices and new product development programs.