Senior Staff Design Quality Engineer

CooperCompanies

About The Position

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

Requirements

Advanced working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR.
Demonstrated knowledge in the application of medical device design controls, verification/validation, risk management principles per ISO 14971, and the use of risk assessment tools such as FMEA, Hazard Analysis.
Intermediate skill in the use of Excel, Word and PowerPoint.
Ability to read and understand highly technical material.
Proficient in reading and writing in English.
Self-motivated and committed to a team approach.
Strong interpersonal, organizational and project management skills.
Ability and experience interfacing with senior leadership and external stakeholders.
Strong oral, presentation and technical writing skills.
Demonstrated skills in decision making, problem solving, negotiation, and influencing without direct authority preferably across a broad spectrum of Quality Engineering responsibilities.
Proven experience leading cross-functional teams in a medical device development environment.
Experience with Change Control, Non-conformance, Deviation, Complaints, HHEs and/or CAPAs.
Strong analytical and problem-solving skills with acute attention to detail.
Excellent communication and interpersonal skills.
Thorough knowledge of statistics and how to apply, evaluate, and provide recommendation from the data.
10+ years experience in Quality Engineering in the medical device industry with a Bachelors Degree, or 8+ years with a Masters Degree, experience in related engineering areas, e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.
Hands ‑ on experience in medical device product development in concept through commercialization, and/or leading design changes, improvements or remediation initiatives in sustaining operations.

Nice To Haves

Knowledge in Knowledge in application of IEC 62304 preferred.
Knowledge in one or more ISO 10993, IEC 62366, ISO 11607, ISO 11137, or ISO 11135 preferred.
Knowledge in women’s health a plus.

Responsibilities

Provide technical leadership to ensure the successful development of Cooper products and ongoing operational support.
Apply knowledge of design controls, risk management, verification and validation principles and quality engineering techniques to ensure safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
Provide expert guidance on scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems.
Partner cross-functionally with R&D, Operations, Regulatory, Supplier Quality, and Clinical teams.
Provide mentorship (including coaching, reviewing, training, delegating work) to peers, leads and less experienced DQEs, and cross-functional engineering teams.
Represent the Quality function on product/process development teams.
Mentor other discipline as needed in the Quality Engineering methodology.
Ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, design reviews, and design changes.
Serve as independent reviewer during design reviews, or conduct DHF audits, as required.
Owner/Approver of one or more processes within the scope of Design Quality.
Manage supplier new tooling to ensure final components are qualified at the supplier and on time utilizing PPAP tool.
Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications.
Specify quality characteristics and inspection plans for components, subassemblies, and finished devices with the Engineering Team.
Review/Approval of PPAP. May serve as PPAP lead.
Lead or Participate in the investigation of complex product problems.
Identify and manage corrective actions resulting from problem investigations.
Evaluate and disposition nonconforming materials and products used in pilot and clinical builds.
Conduct or support health risk assessments in support of the Health Hazard Evaluation, Reporting or Recall processes.
Participate in design reviews to evaluate designs and to help identify alternative design solutions.
Hands on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing.
Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
Contribute to design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.
Approve deviations and design changes, conduct impact assessments, and define/approve implementation plans.
Participate in the development of the master test plans (I.E. trace matrix, VMP….) that encompass design verification, design validation and process validation activities.
Creation, evaluation, and validation of product and process test methods.
Evaluate test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
Define risk management strategy throughout product lifecycle including construction of the Risk Management File, Risk Management Planning, and benefit-risk evaluations.
Identify and manage risk throughout the development process with the use of FMEAs and/or other risk management tools, ensuring effective integration of risk activities throughout product realization process and feedback into design improvements and maintenance of the product risk profile.
Lead the Risk management efforts of the design process and working with design team and management team on managing product and process risks.
Lead strategic initiatives as aligned with organizational quality objectives.
May manage a cross functional team to execute plans.
Actively identify and lead opportunities for improvements across all cross functional departments.
Promote continuous improvement in design control and risk management activities and use of quality tools with design team and other departments.
Comply with applicable FDA and international regulatory laws/standards and the Cooper’s Code of Conduct.
Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
Implement new or updated standards into existing procedures.
Represent Cooper as needed in FDA, notified body, internal, and other audits.
Serve as a technical mentor to QEs, providing guidance on complex quality engineering topics.
Promote continuous improvement and consistent application of design quality tools and methodologies.
Act as a recognized subject matter expert in one or more DQE domains across the organization.
Perform other duties as assigned.