Manufacturing Engineer

Position Overview:

Medical company seeking a Manufacturing Engineer that will be responsible for the design, development and documentation of manufacturing processes and methods, utilizing knowledge of product design, materials, fabrication processes, tooling, equipment, and quality control standards.

Essential Functions:

Design and develop highly capable manufacturing processes for new products. Ensure robust transition from product development thru full rate production ensuring process stabilization.

Design, develop, and qualify new tooling and equipment.

Verification/Validation of processes, machines and equipment to meet requirements of Company procedures. IQ/OQ/PQ protocols.

Experience with equipment/process validation methodology

Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans.

Create and sustain routings and standards.

Interface with all internal organizations with supporting new product development, introductions, technologies, and supporting systems.

Position Qualifications

Required Qualifications:

Bachelor’s Degree in Engineering, preferably Mechanical, Manufacturing, or Process

3-5 years of experience developing and supporting new processing technologies, tool and equipment designs. Direct support/improvement of manual assembly operations.

3 years’ direct experience with generating/sustaining FMEA’s, CAR’s, and NCMR’s.

3 years’ demonstrated experience with project and/or program management skills.

Preferred Qualifications:

Direct application experience in equipment and process automation. Automation design, fabrication, and programming background a plus.

Medical Device experience and familiarization with ISO 13485, FDA 21, Medical Device Directives, and all other applicable industry standards in a highly regulated industry.

Skills and Abilities:

Must be proficient in using software including: MS Office, SolidWorks, (or equivalents)

Experience in design and qualification of machines, equipment, processes, and tooling. Demonstrated ability to write and execute IQ/OQ/PQ protocols and reports.

Experience with generating/revising manufacturing plans/work instructions, process specifications and procedures, training plans, and applying lessons learned.

Must have strong technical, analytical, and extensive problem-solving skills

Interpersonal skills to work effectively with co-workers and external contacts to respond positively to situations, which require cooperation, courtesy and tact.

Ability to multitask and meet deadlines.

Job Type: Full-time

Salary: $65,000.00 to $85,000.00 /year

Experience: