May 19, 2021
This Manufacturing Engineer's primary initial focus will be to work as part of cross-functional team in developing new products & their processes using design & development systems in accordance with FDA & international regulations. In addition to this, the position will be responsible for developing, planning and implementing the assembly & test of our precision electronic, electro-mechanical and mechanical components, through cross functional departmental involvement. The Manufacturing Engineer will estimate production times, tooling & gauging requirements and other possible related costs in support of management planning as well as confer with management, R&D / engineering and other staff regarding manufacturing capabilities, schedules and other considerations to facilitate production. Work will be performed under general supervision with latitude for independent judgment and a high level of proficiency.
Supports Supply Chain and Supplier Quality in validation of supplier inspection data.
Leads the resolution of manufacturing or production quality related issues.
Plans and designs manufacturing processes in a high tech medical device manufacturing plant.
Supports production matters related to general operations, safety, delivery, cost & efficiency.
Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization.
Identifies & develops tooling / gaging needed in order to achieve manufacturing goals according to product specification.
Identifies Quality & Safety improvements for the production team.
Trains production employees (Internal & External) as necessary on new processes and equipment
Assures timely and effective project completion according to the project plan & budget.
Upholds the quality policies of the Company.
Supports the creation and maintenance of our Work instructions, DMR’s, PFMEA’s & QIP’s per our QA System requirements.
Supports Design Transfer, R/D, Engineering & procurement with evaluations of prototypes, validation of manufacturing processes and continuous improvement technical activities as well as MRB related items.
Other duties as required.
Bachelor’s degree with a minimum of 3-6 years’ work experience in a manufacturing environment.
Strong working knowledge of blueprints, GD&T, JIT (Just in Time) manufacturing, Standard Work, DOE (Design of Experiment) & make vs. buy analysis
Strong working knowledge of metrology methods, and general manual inspection methods (including hard gaging). Also require experience in test method validation (including Gage R&R), PPAP development and control plan design.
Experience with the following regulations: FDA 21 CFR Part 820 – FDA Quality System Regulation
Good computer skills, with knowledge of Word, Excel and Solid Works. (Matlab experience a plus)
Prior experience with Six Sigma and lean manufacturing required. Typically requires a Six- Sigma certification and or equivalent experience.
Ability to solve problems by identifying relevant facts and key issues rapidly.
May be required to work varying work schedules and weekends depending on customer requirements.
Must have excellent communication and customer service skills, be a team player, able to multitask and self motivated. Ability to develop and present project plans to upper management.
Physical Requirements And Work Environment
Work will be performed in a manufacturing warehouse environment.
Ability to lift 25 lbs weight.
Frequently required to walk, stand.
10-20% travel to suppliers and customers.