Job title: Manufacturing Engineer III Location: Mansfield, MA (02048) Duration: 6 months Schedule: Monday to Friday, Business Hours
Responsibilities: • Works within cross-functional project teams including Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve manufacturing processes used to manufacture surgical products for the medical device industry. • Designs, specifies, develops, and purchases manufacturing tooling, fixtures and equipment. • Manages the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of products. • Support and guide transfers internally within plant and externally with suppliers. • Supports the selection and validation of replacement materials, such as polymers, metals, and adhesives used in the manufacturing of products. • Writes and implements Manufacturing Procedures and Work Instructions. • Creates, updates and maintains BOMs, Routers, and DMRs. • Works as a recognized manufacturing and process technical expert who can provide process engineering knowledge and oversight to resolving manufacturing-related problems with existing products and processes. • Champions improvement processes for rework, scrap, and labor variance reduction / elimination in the plant processes. • Supports Material Review Board process by investigating and resolving manufacturing and supplier quality concerns. • Identifies and provides innovative new manufacturing technologies from industry best practices that can be applied to products and mfg processes. • Represents the Manufacturing Engineering group on strategic projects in Manufacturing and Sourcing.
Education: • Bachelor's degree in Mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent is required.
Experience: • A minimum of 6 years of engineering industry experience is required. • Experience in the medical device industry is required. • Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PO qualifications as related to medical devices is required. • Working knowledge in manufacturing processes such as metal processing (machining, polishing, welding), plastics processing, and mechanical assembly is required. • Working knowledge of machine and tool design, equipment design, and the startup of new equipment is preferred. • Experience working in a cleanroom environment is preferred. • Six Sigma Statistical Process Analysis knowledge is required with certification preferred. • Mentor and assist Blackbelts/Greenbelts on projects as needed. Assist with tools and Mintab software. • Knowledge on how to troubleshoot and analyze effectiveness of manufacturing processes is required. Experience in implementing actions to improve equipment uptime, yield, efficiencies, and quality of production is required. • Experience in Lean Mfg and Continuous Improvement Methods is preferred. • Knowledge of financial accounting and analysis methods to assess product standard costs, project values, product cost improvements and capital purchases is required. • Strong communication, team building, and cross-functional coordination skills are required. • Experience with Agile and Oracle data systems is preferred. • Ability to travel up to 10% domestically is required
Note: Would be looking for ME’s that have done IQ, OQ, PQ’s, strong Solidworks skills and knowledge of Medical Device regulations and cleanroom practices is desired.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $54.00/hr.