Director, Device Quality Engineering
Location: Cambridge, Massachusetts
Posted: February 01, 2017
Reference ID: R-33338
The Director of Device Quality Engineering will lead and build a dynamic team that supports new product development across the organization. This position will lead a team of direct reports (Quality Engineers) responsible for design assurance for new and existing drug delivery device technology. This team is responsible for accurate, independent evaluation of Design History File documentation, Design intent and Design Quality. The team will also translate design requirements into processes that ensure quality attributes in the design are maintained and are practical for manufacturing. The Director may also be the Device Quality Project lead on various combination product teams and/or Quality Workstream Lead for major 3rd party engagements.
The position will work closely with Device Engineering Leadership to guide program teams and drive continuous process improvement, and will enable and empower direct reports to partner with their cross-functional team members to enable the development of innovative technology. Programs are focused on early development through transition to manufacturing, then sustaining support once products are commercialized. This work also comprises risk management, reliability and failure analysis, and quality planning. Other responsibilities include determining appropriate test, verification and validation parameters to ensure components and products meet specifications requirements.
The position is also responsible to present and defend device-related aspects of products in internal and external audits and inspections. The position will implement and maintain the Device Quality operating model in the Cambridge location and will have direct reports in Cambridge and Thousand Oaks, California. The position will be an active member of the Device Quality Leadership Team relative to strategy, innovation, process improvement, and implementation.
Up to 20% domestic and international travel.
• Directs and in some cases performs design control activities requiring judgment in the planning, evaluation, selection and the substantial adaptation of best practice engineering techniques, testing procedures and criteria.
• Ensures teams work closely with product development engineering and supplier/contractor teams to establish system design specifications and product requirements.
• Ensures teams work closely with design, development, quality, regulatory, and supplier/contractor teams to establish and document the master verification and validation plans in conformance with the system design specification and sound testing principles.
• Oversees or assists in planning, coordinating and execution of design verification and validation testing to directly support the master verification and validation plans, including any additional activities such as Highly Accelerated Life Testing (HALT) / Highly Accelerated Stress Screening (HASS) and International Electromechanical Commission (IEC) 60601-1-x testing, Human Factors Engineering (HFE) studies, clinical trials and other standardized test methods.
• Participates with the engineering team to establish and drive the design Failure Mode and Effects Analysis (FMEA), Failure Mode, Effects and Criticality Analysis (FMECA) and other risk related activities (International Standards Organization) ISO14971.
• Facilitates the achievement of business goals for device reliability, quality, customer satisfaction, cost and safety by identification, development, and accomplishment of key initiatives supporting the business objectives and operational goals for device quality improvements, customer satisfaction, supplier and component initiatives, and safety.
• Partners with cross-functional peers to drive and enable product reliability design improvements via ongoing research, design and further development of existing products to continuously improve device reliability, quality, and customer satisfaction.
• Ensures verified and validated product changes with completed documentation in accordance with established regulations, procedures, and guidelines, including data-supported rationales and conclusions.
• Ensures inspection readiness and documentation robustness for programs/products in scope and for Device Quality processes.
Doctorate degree and 4 years of Quality, Engineering or Scientific experience
Master's degree and 6 years of Quality, Engineering or Scientific experience
Bachelor's degree and 8 years of Quality, Engineering or Scientific experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Degree in Scientific or Engineering field
Previous experience in Quality engineering and commercialization process with drug delivery devices and combination drug/device products
Demonstrated ability to build and develop the best team, and creating a "great place to work" environment
10+ years of business experience, leading technical organizations in multiple parallel and virtual environments
American Society for Quality Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified ISO 13485 Auditor credentials, Six Sigma Black Belt
Experience with quality systems including: 21CFR Part 820, Part 4 Combination Products, Medical Device Directives (MDD), ISO 13485:2003
Design assurance experience in the design and manufacturing scale-up of drug delivery devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal) Familiarity with Printed Circuit Board (PCB) / Printed Circuits Assembly (PCA) assembly / fabrication, and development / Verification & Validation of firmware
Strong background in requirements management, configuration management, advanced problem-solving, risk assessment, and statistical analysis
Demonstrated accountability for successful delivery of multiple complex, cross-functional New Product Introduction (NPI) or similar projects
Deep knowledge of device and combination product-related regulations, guidance, and standards including: European Union (EU) / Japan Asia Pacific JAPAC)
Ability to apply situational leadership concepts across various intra and inter-departmental matters
Demonstrated time management, decision making, presentation, organization, and negotiation skills
Ability to converse technically with mechanical, electronic, software, clinical, regulatory and quality engineering disciplines
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.