The Manufacturing Engineer is responsible for manufacturing engineering, production, product support, and servicing to achieve world-class results. Responsible for manufacturing engineering and production of both durable and disposable products.
Essential Duties and Responsibilities
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary from time to time.
- Drive manufacturing engineering and work closely with R&D and Quality to effectively transition products to manufacturing; serve as a key representative and contributor on a project development team;
- Help define operations processes, including hands-on definition of MPIs, TPs, DHRs, etc.;
- Conduct PFMEA analyses; define and execute process validations;
- Work with external vendors including contract manufacturers;
- Contribute to operations initiatives, apply analytical and statistical methods to continually improve quality, reduce cost, reduce cycle time and simplify processes;
- Ensure compliance with company policies, procedures, and regulatory;
- Support failure investigations; collaborate closely with cross-functional groups;
- Collaborate cross-functionally to define product servicing strategy and infrastructure; Establish L1 (service desk) and L2 (break fix) support;
- Other tasks as requested by management.
Qualifications and Education
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree in engineering, manufacturing, industrial engineering, or a related discipline preferred.
- 3-5 years' experience in one or more disciplines of manufacturing operations (e.g., manufacturing, assembly & test, manufacturing engineering, subcontract, service);
- 50 percent travel;
- Medical device experience required;
- Technical knowledge of assembly and test of electronic equipment;
- Working knowledge of manufacturing engineering, ERP and PLM systems, quality assurance and lean manufacturing;
- Must be flexible, detail oriented, and extremely organized, with a positive outlook, enthusiasm, and high energy; ability to thrive in a rapidly-growing, dynamic, drive-for-excellence environment;
- Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other national and international regulations and standards;
- Experience at start-up companies preferred;
- Controlled environment room (CER) experience preferred;
- Excellent communication skills; written, verbal and presentation;
- Microsoft Office (Word, Excel, Project, PowerPoint, Visio) skills;
- SolidWorks, Adobe Acrobat Professional, Adobe Illustrator, Zebra Printer hardware/software