Sr. Manufacturing Engineer CardioFocus
THIS JOB HAS EXPIRED Department:Operations (Marlborough, MA)
Job Reports To:Vice President, Operations
The candidate will be responsible for technical and Operations support to a team of Group Leaders, Assemblers, and Engineers/Technicians in a controlled manufacturing environment. Efforts will focus on designing and developing equipment, tooling, fixtures, and/or processes required for new products, product changes and enhancements that will support product throughput and quality goals. Candidate will provide leadership, interface, and support for peers in other departments including Quality, Materials Management, R&D, and Finance.
Essential Duties and Responsibilities include the following -
Providing training, direction and manufacturing support for a team comprising of Group Leaders, Manufacturing Assemblers and Engineers/Technicians.
Working with Manufacturing Manager to assure the team's efforts are in full compliance with company Quality policies, ISO and other relevant regulations, company SOP's and manufacturing procedures.
Understanding and interpreting engineering and production drawings and procedures.
Training assemblers to production drawings and procedures in the following areas -
Assembling components into complex sub-assemblies;
Performing intermediate assembly tasks such as trimming, polishing, sanding, cleaning, bonding, curing, etc.
Packaging products in preparation for sterilization processing.
Working directly with Manufacturing Manager and Associate Engineer to collect and analyze relevant process data. Use data to identify, explore, and implement process improvements.
Working with R&D Engineers to support and introduce new product initiatives.
Preparing documentation including NCMR's, ECN's, Manufacturing Waivers, etc. in support of assembly, packaging, and sterilization operations.
Providing leadership and support for manufacturing, sales and quality with regard to complaint resolution, product testing, CAPA investigations and product documentation reviews.
Setting up standard and special purpose laboratory equipment to test and evaluate devices at different stages of assembly.
Formulating tests, calibrations and procedures to maintain precision accuracy of devices.
Communicating daily to VP Operations all pertinent manufacturing process, quality, or technical activities including process improvement, equipment and/or material issues.
Additional tasks and responsibilities as assigned.
Display willingness to make difficult decisions and include appropriate personnel in decision-making process; exhibit sound and accurate judgment.
Prioritize and plan work activities efficiently; set effective (SMART) goals and objectives for self and team.
Demonstrate accuracy and thoroughness; monitor own work to ensure quality.
Observe all safety and security procedures; report and manage potentially unsafe conditions, specifically in and around manufacturing clean rooms.
Follow instructions and respond to management direction appropriately; take responsibility for own actions; forge positive relationships with all levels of management and with all departments.
Show initiative by undertaking self-development activities, seeking increased responsibilities, and taking advantage of learning opportunities.
Display original thinking and creativity; meet challenges with resourcefulness; generate suggestions for improving work.
Bachelor's Degree in an Engineering discipline preferred. Significant applicable experience may be considered in lieu of degree. Minimum of seven years' engineering experience in a regulated medical device manufacturing environment. Solid knowledge of QSR, ISO 13485, and the MDD is critical. Familiarity of LEAN principles preferred. Must have ability to read and understand SOP's, engineering drawings, and manufacturing procedures. Basic machine shop skills a plus. Candidate must speak and understand English effectively. Excellent communication skills (verbal and written) required. Ability to collect, collate, and present data effectively.
While performing the duties of this job, the employee is regularly required to be on their feet and mobile for 8 to 10 hours a day, move throughout the facility to accomplish required tasks, visually prepare and analyze data, work at a computer, and review assemblers' work using a microscope and/or small tools and fixtures. Ability to lift/move/carry for short distances equipment weighing up to 25 lbs. Specific vision requirements of this job include close vision and ability to adjust focus.
Please submit your resume and cover letter to: Lindsay Hebert at firstname.lastname@example.org.
||500 Nickerson Round |
Marlborough, MA 01752
THIS JOB HAS EXPIRED