Manufacturing Engineer 2

Acumed LLC

Come join a team where People make the difference!As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.

Job Scope

The Manufacturing Engineer (ME 2) at Acumed supports medical device lifecycle, focusing on production, new product development, process improvement, and waste elimination. The ME 2 ensures compliance with GMPs and co-owns targets for COGS, OTD, and NPI. Ideal candidates are passionate about manufacturing, effective in regulated environments, and possess strong communication and analytical skills. They should be comfortable on the shop floor.

Duties/Responsibilities

• Develops, designs, and implements advanced production fixtures
• Develops and implements new production Routings, In Process Inspection (IPI) and Bills of Material (BOMs)
• Supports corrective/preventative action activities (CAR/SCAR)
• Utilizes statistical methods to verify process capability and the efficacy of process controls
• Prepares and analyzes operational metrics to identify trending and attention areas.
• Leads cell level Process Improvement (Pi) initiatives and implement lean tools
• Develops manufacturing plans and timelines for new product release
• Reviews new product design for manufacturability prior to production release
• Coordinates Process Development Runs and conducts Production Readiness Reviews (PRR)
• Develops and executes Process Validation protocols and reports
• Implements and improves upon existing manufacturing processes
• Communicates effectively with cross-functional team members and vendors

Qualifications

• B.S. Degree in Engineering (Mechanical, Manufacturing, Industrial) or equivalent
• Basic 3D CAD experience in PTC Creo, Autodesk Inventor, Solidworks, or equivalent
• Skilled at data driven problem solving and root cause analysis.
• Ability to effectively communicate (read, write, speak) in English.
• Must excel working in a team environment.
• Basic knowledge of CNC machining processes and/or other manufacturing processes
• 2+ years manufacturing engineering or related experience
• Previous medical device experience (preferred)
• Applied 3D CAD experience in PTC Creo, Autodesk Inventor, Solidworks, PRO-E or equivalent.
• Basic understanding of Geometric Dimensioning and Tolerancing (GD&T)
• Basic understanding of Process Validation (IQ, OQ, and PQ) requirements
• Understanding of statistical tools such as control charts, trending, and capability with experience in Minitab, JMP or equivalent
• Experience in a regulated manufacturing industry desired
• Knowledge of FDA and ISO 13485 Regulations
• Understanding of Risk Management and experience with tools such as FMEA

Target Compensation: $81,805.22 – $99,984.16

Benefits: Medical, Dental and Vision insurance, 401k matching, + more.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.