Principal Advanced Manufacturing Engineer

Precision Optics Corporation; Littleton (MA); Presencial; USD 110 000 - 140 000; Tempo integral

Resumo da oferta

Precision Optics Corporation seeks a senior Manufacturing Engineer to lead design transfer out of R&D and to escalate manufacturing capabilities. You will develop processes, tooling and fixtures, target cost reductions, and train technicians to ensure high reliability and manufacturability.

You will coordinate with QA, R&D and suppliers, supervise maintenance, document procedures, and drive continuous improvement within ISO cleanroom environments. In-person work in Massachusetts is expected.

Qualificações

• Requires a Bachelor/Master’s degree in engineering or related discipline.
• Six Sigma Black Belt is a strong plus.
• 10–15 years of related experience.
• Experience with complex electro-mechanical and/or opto-mechanical products and processes.
• Experience with disposable or single-use devices is preferred.
• Proficient with Word, Excel, Project and PowerPoint; DOE and statistical tools.

Responsabilidades

• Lead design transfer out of R&D and develop manufacturable products.
• Develop, implement and improve manufacturing capabilities for productivity, quality and cost.
• Train technicians on equipment operation, procedures and inspections.
• Plan, schedule and manage projects aligned with corporate goals.
• Create and maintain documentation (concepts, tool drawings, shop orders).
• Provide engineering support to production for troubleshooting and issue resolution.
• Coordinate with QA/R&D, outside vendors and supply chain.
• Supervise preventive maintenance of equipment and tooling.
• Ensure GMP compliance and FDA regulations in manufacturing.

Conhecimentos

Electro-mechanical

Opto-mechanical

Manufacturing processes

Single-use devices

DOE

Statistical analysis

Design of Experiments

Formação académica

Bachelor/Master's degree in engineering

Six Sigma Black Belt (strong plus)

Ferramentas

Word

Excel

Project

PowerPoint

Descrição da oferta de emprego

Description

Lead design transfer out of R&D. Develop, implement and improve manufacturing capabilities. Assist Manufacturing capabilities in productivity, product quality and cost through the development and implementation of novel and effective methods, tools, equipment, and processes. Contribute to product design improvements intended to achieve higher reliability, serviceability, and manufacturability. Train technicians and manufacturing personnel on manufacturing equipment operation, procedures and inspections.

• Provide best-practice leadership within product development staff to ensure that products under development are optimally manufacturable that may include but not be limited to mechanical assembly/dimensioning/tolerances, electrical wiring, materials selection and fabrication methods.
• Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero-defect level as well as low product cost.
• Perform Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), and DOEs.
• Establish best practices and author manufacturing procedures; develop Bills of Material.
• Investigate benefits and features of capital equipment and generate capital appropriation justifications.
• Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions.
• Provide engineering support to production department in troubleshooting and resolving technical problems.
• Coordinate work with outside vendors, assigned technicians and tool room personnel.
• Plan and schedule projects in a manner consistent with corporate objectives.
• Support prototype and pilot production of new products, product changes, and enhancements in coordination with the R&D, Manufacturing and Quality Control functions.
• Supervise the complete, accurate, and timely preventive maintenance of equipment and tooling.
• Supervise production of consumables and hardware: schedule production to meet demand; build, test, package and label finished goods. Coordinate sterilization with Quality Assurance function. Coordinate distribution with the Supply Chain function.
• Maintain factory GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
• Ensure that all regulatory and internal policies are followed

Requirements

• Requires a minimum of 10-15 years’ related experience
• Demonstrated experience with complex electro-mechanical and/or opto-mechanical products and manufacturing processes is required, low to medium volume is preferred
• Demonstrated experience with disposable or single-use devices is preferred
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel. Must be competent with Word, Excel, Project, Power Point applications.
• Experience with Design of Experiments and statistical analysis packages.

Education Requirements

• Requires a Bachelor/Master’s degree (or equivalent) in engineering or related discipline
• Six Sigma, Black Belt Certification is a strong plus

Supervisory Responsibility

Lead a small team of Manufacturing Engineers

Working Conditions

This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms.

Physical surroundings

This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. Manufacturing & laboratory environments require the use of electrical and mechanical equipment and tools.

Physical Effort

While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, manufacturing tools, equipment, products, and systems; reach with hands and arms; talk and hear.

Work Schedule / Travel

In-person, Monday to Friday; occasional travel of 10-15%. Occasional presence at other locations to include Gardner, MA & Portland ME

Other Requirements

Applicants must have US citizenship or US person status.