Interested in developing and overseeing the manufacturing process for a first-in-class oral health product that will directly affect the health of millions and have a groundbreaking impact on the dental industry? This is an opportunity to shape and define, have ownership, and be instrumental in our growth.

The Manufacturing Engineer is a hands-on role that will be responsible for implementation of the overall manufacturing and manufacturing test strategy and processes for Fresh’s oral care products.

The person in this role has broad ownership of mechanical and electro-mechanical assemblies that will include developing the processes and procedures, fixture design, assembly flow, testing methodologies, and ensuring compliance with ISO-13485 and GMP.

The Manufacturing Engineer is an excellent cross-functional collaborator, working with internal and external resources across multiple disciplines. This engineer will also possess an intense attention to detail as well as an innate curiosity to delve into the data and drive for continuous improvement.

The Manufacturing Engineer will work with the Engineering Design team to provide feedback (i.e. DfX), lead pFMEA, and closely work with contract manufacturing partners to ensure high quality with high productivity while managing costs.

What you will do:

Work directly with R&D, Project Management, NPI, Operations, and other internal teams in the development and release of new products for aggressively scheduled programs in accordance with the new product introduction deliverables.
Coordinate with contract manufacturing NPI teams and Operations on program requirements, NPI builds, manufacturing & test instructions, manufacturing line qualification and validation plans.
Define, coordinate, and achieve NPI prototype build plans and pre-release quality assurance activities at design center and factory.
Influence development teams to improve the manufacturability of new product designs by applying DFM (Design for Manufacturing) principles to all new product designs and driving PFMEA on new platforms designs.
Identify and drive design and process improvements for cost reduction.
Report program status and potential areas of concern to the development team, NPI organization, and Factory.
Facilitate interaction between design engineering and manufacturing to improve yield including failure analysis to support new product quality.
Manage major risks and issues through effective contingency plans and proper escalation.
Oversee design of manufacturing fixtures, toolings, and test jigs for volume scale production.
Analyze and recommend corrective action in case of any design failure.
Help to develop product test plans according to manufacturing process instructions.
Develop strong working relationships with both Engineering and Production teams to ensure all company objectives can be met.
Installs new equipment and ensures that it operates correctly; trains others to operate new machinery.
Lead the transfer of the product from the pilot manufacturing line to the volume manufacturing line.

Required profile/experience:

B.Sc. or M.Sc. in Mechanical Engineering, Electrical Engineering, or similar discipline.
10 or more years of experience working with electro-mechanical device manufacturing, preferably in an ISO-13485 environment.
Experience working in a start-up / NPI environment.
Excellent understanding of electro-mechanical assembly processes.
Strong communication and interpersonal skills.
CAD skills in some form of Mechanical CAD package - Solidworks preferred.
A proven track record in working with cross-functional development and manufacturing teams.
Ability to be a creative and collaborative team player.
Experience with comprehensive analysis of technical issues, such as system performance analysis and root-cause of product issues.
Knowledgeable in production control processes, data analysis/interpretation GR&R, Cp/Cpk and correlation analysis.
Measures and manages OEE (Overall Equipment Effectiveness).
Flexibility and comfort working in a quickly changing environment.
Proven track record in working independently under high pressure and comfortable working in dynamic environment.
Ability to travel internationally 30% of the time

Benefits:

Competitive salary and equity
Health, Dental and Vision, including PPO, Kaiser and HSA. 100% employee + 50% dependent coverage
Robust benefit options through our PEO including Life/ AD&D, disability insurance, global travel assistance, identify theft, FSA health, dependent care & more
Hybrid work model and generous vacation
Retirement options: 401(k), IRA
Physical, emotional, and financial wellbeing perks
Commuter benefits
Employee Assistance Programs

We built our benefits package to exemplify our commitment to health, a work/life balance that fulfills you while you’re here and supports you when you’re not (and some added fun). https://freshhealth.com/careers/

Proclaim is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. You do not have to match all the listed requirements exactly to apply. We believe that our organization and culture are made stronger through diverse perspectives and experiences

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