Founded in 1997, Goddard is a dynamic, 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.
Why you should join us:
- Project diversification: Our teams have helped to re-imagine and build products ranging from implantable heart pumps to boat monitors to flying cars.
- On-site partnership model: Our engineers become a part of our clients’ team. Many of our clients opt to host our engineers on-site for the duration of their project. Every Thursday, the entire Goddard staff gathers in our Beverly and San Diego offices to discuss projects. The upshot? No matter where you are, you’re always supported by the whole team.
- We care about culture: From our “dress-for-your-day” policy, Athletic Club and Women’s Network to social hours and summer Fridays, we believe in taking care of our teammates.
Goddard is seeking a Senior Quality Engineer to join our team. Quality engineers assist in the planning, development, implementation, communication, and maintenance of a company’s quality management systems, polices, documentation, data, and customer-specific requirements.
About the Role:
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Establishes statistical confidence by identifying sample size and acceptable error and determining levels of confidence.
- Develops experiments by applying full and fractional factorial techniques.
- Develops sampling plans by applying attribute, variable, and sequential sampling methods.
- Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes.
- Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
- Prepares reports by collecting, analyzing, and summarizing data; and making recommendations.
- Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, participating in professional societies, and maintaining ASQ-certified quality engineer qualification.
- Contributes to team effort by accomplishing related results as needed.
- Ensures products adhere to company and industry quality standards.
- Brainstorms ideas to create solutions for identified problems.
- Bachelor’s degree in engineering or equivalent discipline or equivalent work experience.
- 5 years minimum hands-on working knowledge of the FDA QSR and ISO 13485 required.
- 5+ years in a manufacturing environment preferred.
- Experience with:
- Test methods and standards for the design, verification, and validation of medical device products.
- Risk management, and risk assessment techniques, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.
- Root cause analysis experience preferred.
- 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.
- Coordination and performance of internal process/product audits.
- Performance process capability studies.
- Programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and performance of gage R&R studies preferred.
- Good oral and written communication skills.
- Ability to communicate effectively with all levels of staff and management, both internal and external.
- Capacity to work independently from general supervision (must be self-motivated once given direction/guidance).
- Excellent organization skills with the ability to perform multiple tasks and obtain results working within strict time frames.
- Strong attention to detail.
- Proficient in MS Office software including Word, Excel, and PowerPoint.
- Ability to read and interpret assembly and component drawings and engineering specifications.
- CAD Data Analysis (measurement & manipulation).
- Basic knowledge of operating measurement equipment (CMM preferred).
- Good knowledge of manufacturing processes.
- Above average math skills (sound knowledge in both statistics and calculus).
COVID-19 Consideration: We require all our 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.
Goddard believes that everyone is entitled to fair opportunities and equal employment rights. We comply with all applicable laws prohibiting discrimination in hiring and the terms and conditions of employment including, but not limited to, compensation, promotion, discipline, or termination. Goddard is firm on its policy to provide equal employment opportunity for all employees and applicants on the basis of qualification and merit and will not discriminate on the basis of race, color, creed, religion, national origin, age, disability, genetic information, sex, sexual orientation, gender identity, marital status, veteran status, public assistance status, membership or activity in a local commission, or any other legally protected status in accordance with applicable local, state, and federal laws.