About Goddard: Founded in 1997, Goddard is a full-service product development and engineering firm specializing in the design and development of medical technology, life science and industrial products. Drawing from the collective expertise of its experienced designers and engineers, Goddard’s mission is to deliver outstanding solutions that positively impact lives.
We are looking for an experienced and motivated candidate to join our Quality team. This role will provide pre-market product development Quality Engineering support to ensure delivery of highest quality products to the customer. The Senior Design Quality Assurance Engineer develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet Goddard’s, customer, and regulatory requirements. It serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, and corporate quality goals and priorities.
The Senior Design Quality Assurance Engineer position is responsible for various design quality engineering functions in support of product development on Medical Device Development, such as leading Risk Management activities, collaborating with development teams throughout the Software Development Life Cycle, guiding teams through Design Controls, Design Verification and Validation, Submission Strategy and ensuring compliance to the Quality Management System.
What You'll Do:
- Provide support of at all stages of Product Development
- Understand and help implement global processes of the QMS related to Design Controls
- Work with product development teams and other QEs to assure compliance to the QMS
- Responsible for the Authoring, Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its compliance per product
- Ensure FDA and other regulatory knowledge and experience is applied to risk assessments
- Work with the Crossfunctional Product Development and Engineering teams, Quality Control, Client, and Service groups to support gathering, analyzing, and translating internal and external customer feedback to define product requirements while improving product quality and overall customer satisfaction
- Support sustaining and continuous improvement projects
- Risk Management planning, reporting and the development of critical risk documentation - summarize the product’s risk profile and risk acceptability
- Coach and mentor cross-functional team members in the application of Design Control and Risk Management
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Successfully navigates in grey spaces and provides logical and creative guidance to teams
- Supports Product Development and Engineering teams, Quality Control and Service groups to identify opportunities to drive efficiency and effectiveness of through production release (commercial release)
- Ensuring that the language surrounding requirements are free of ambiguities and conflicting requirements
- Support the team with activities to support all regulatory submissions [i.e., 510 (k), PMA, etc.]
- Support Verification and Validation activities, including assisting in the development and review of V&V requirements, protocols and reports as well as other relevant DHF documentation
- Collaborate with the team to review and approve Design Control documents and DHF deliverables
- Develop statistically sound sampling plans and perform data analysis
What We'll Expect from You:
- Highly motivated, self-starter
- Excellent written and verbal communication skills
- Able to work independently, with minimal daily guidance
- Excellent cross-functional team participation skills
- Highly organized and detail oriented
- Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software, manufacturing software, database software
Skills and Qualifications: Quality assurance engineers assist in the planning, development, implementation, communication, and maintenance of a company’s quality management systems, polices, documentation, data, and customer- specific requirements.
A list of standard qualifications and skills for the role may include:
- Development of inspection and work instructions
- Part inspection, including layout, in process, final, and receiving using all types of mechanical inspection
- Preparation of inspection reports
- Basic knowledge of operating measurement equipment (CMM preferred)
- Ability to read and interpret assembly and component drawings and engineering specifications
- CAD Data Analysis (measurement & manipulation)
- Good knowledge of manufacturing processes
- Knowledge of Six Sigma and Lean Manufacturing Processes
- Coordination and performance of internal process/product audits
- Performance process capability studies
Education & Experience Requirements:
- Bachelor's Degree required in related field (Biomedical, Software, Electrical, Mechanical Engineering or equivalent), Advanced degree is a plus (M.S. in a Life Science, or equivalent)
- 5 years of Design Assurance, New Product Development, Design Quality Engineering or related medical device experience
- In depth familiarity with 21 CFR820, ISO 9001/ISO 13485 and the industry quality requirements associated with product design & development as well as product risk management (ISO 14971)
- >5 years in a manufacturing environment preferred
- 5 years minimum hands-on working knowledge of the FDA QSR and ISO 13485 is required
- Experience with test methods and standards for the design, verification, and validation of medical device products
- Experience in risk management, and risk assessment techniques, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.
- Root cause analysis experience preferred
- Above average math skills (sound knowledge in both statistics and calculus)
- Experience with authoring inspection plans and programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and performance of gage R&R studies preferred
COVID-19 Consideration: We require all employees to be fully vaccinated in order to safeguard the health and wellbeing of our employees, families, customers, and visitors.
Please note: Presently, Goddard does not sponsor employment visas.