Manufacturing Engineer 2

Acumed LLC
Addison, TX Full Time
POSTED ON 3/30/2023 CLOSED ON 5/31/2023

What are the responsibilities and job description for the Manufacturing Engineer 2 position at Acumed LLC?

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) is responsible for supporting the life cycle of Acumed medical devices by meeting operational objectives in production and new product development. This includes developing, integrating, validating and improving production processes and systems. The ME owns continuous improvement of existing processes through the elimination of waste and / or the adoption of new methods of manufacturing. The Manufacturing Engineer is a co-owner of Acumed’s Cost of Goods Sold (COGS), On Time Delivery (OTD), and New Product Introduction (NPI) targets. The Manufacturing Engineer supports Acumed’s quality-first culture by ensuring Acumed processes are aligned to regulated Good Manufacturing Practices (GMPs). The ideal candidate has a passion for manufacturing and can be effective in a quality-first, highly regulated environment. The Manufacturing Engineer must have excellent verbal communication and technical writing skillset with demonstrated experience using analytical methods to solve problems. The Manufacturing Engineer must have a “go and see” mentality and feel comfortable in a shop floor environment. 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/CAPA) 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 department level Process Improvement initiatives and implements 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 Prepares new equipment proposals including ROI justification Manages smaller capital project AFEs from preparation through implementation Implements and improves upon existing manufacturing processes Communicates effectively with cross-functional team members and vendors Qualifications 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 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 careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying. With more than 100 autonomous manufacturing and service businesses, Marmon Holdings, Inc. may be the biggest company you’ve never heard of. Part of Berkshire Hathaway Inc., Marmon is a global industrial organization comprising 11 diverse groups with 20,000-plus employees and $10 billion in annual revenue. As leaders in every industry we serve, Marmon companies have earned a great degree of independence. And our people thrive on an entrepreneurial spirit. At the same time, our group structure gives every Marmon company access to the expertise of other Marmon companies serving the same or related markets and customers – all with the support of the entire Marmon organization. Working together, we become something more than the sum of our parts. We become the most reliable solution provider for a broad range of industries and customers worldwide. In every case, Marmon’s success is due to our people. People with talent, drive and high ethical standards. People who are following their passions and building their careers across Marmon. Want to learn and perfect your craft? Want to sharpen your skills while helping to solve challenges for our customers and our world? Looking for a chance to grow within – or perhaps outside – your field? Find a Marmon company that matches your passion. And see what you can do with the support of a team that values your contribution.

Salary : $10 - $0

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