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Company Contact Info
- Westford, MA 01886
- Phone: 480-448-4257
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Volt • Westford, MA
Posted 10 days ago
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Volt has an opening for a Sustaining Engineer with our client in Westford, MA. We are looking for an Electrical Engineer with experience in Design Engineering. Volt's Client is an American leading healthcare company.
This position will be a sustaining design quality engineering position supporting the FFR and OCT hardware portion of our client business.
Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective and cost-efficient practices to execute processes; continually evaluates their effectiveness and appropriateness.
- Support all sustaining activities around catheter and capital hardware console manufacturing including end of life, supplier change requests, Global compliance standards, IFU/Label changes, support of regulatory submissions, corporate programs, literature review, and all supporting quality system elements
- The position will also support the following manufacturing elements:
- Production support process validation, and design changes and design verification and validation
- Interface with vendors for components
- Support CAPA investigations
- Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
- Protocol and report writing
- Work with cross functional teams as required
- Develop and implement process improvements
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- Works with standard office equipment such as telephone, cellular phone, fax/copier, and a personal computer with standard office software.
- Knowledge of analog electronics
- Experience with fiber optics is beneficial
- Working knowledge of laser equipment is beneficial
- Capital equipment experience is preferred
Works primarily in a standard office environment with air conditioning, good lighting with a low to moderate noise level. May also visit research labs, testing labs, production and other areas as well as vendor facilities as necessary.
- Bachelor of Science in electrical/electronic engineering or related engineering field.
- A minimum of three years of relevant work experience in performing the layout construction, and evaluation of a variety of Printed Circuit Boards, fixtures and tools.
- Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks.
- Demonstrated personal computer skills, including spreadsheet, word processing, database management, and specialized applications.
- Advanced credential or professional certification in a relevant discipline/concentration desired.
- Six-Sigma knowledge and experience desired.
- Training and experience in manufacturing processes and methods desired, especially in the manufacturing of medical devices.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 25%, including internationally.
- Ability to maintain regular and predictable attendance.
Volt is an Equal Opportunity Employer