Adecco Staffing is assisting a well-known Medical Device Manufacturing facility in Chelmsford MA with their needs for a Manufacturing Engineer II.
Pay : $33 / Hr
Shift / Hours : Monday - Friday 8am - 5pm
POSITION SUMMARY :
The Manufacturing Engineer II will have capability within engineering disciplines to support Manufacturing and Quality Compliance efforts throughout the business. Provide support as an engineering resource on cross functional teams focused on sustaining and implementing continuous improvements to the catheter product lines. These product lines include Intra-Aortic Balloon (IAB) catheters, pacing catheters, thermodilution catheters, cholangiography catheters, sheath introducers, Berman angiographic balloon catheters, and Wedge pressure catheters.
The Manufacturing Engineer II primary function is to provide day to day support of the catheter manufacturing floor operations from an engineering perspective. The engineer will drive investigations tied to non-conforming product as well as processing general Non-Conformance (NC) tasks. In addition, the Manufacturing Engineer II is responsible for driving continuous improvement projects focused on the manufacturing line to reduce costs, while maintaining quality compliance, using the application of lean problem- solving tools. Accountable for deliverables in good documentation practice, the design control process, and other required methods of documentation.
PRINCIPAL RESPONSIBILITIES :
- Continuous Improvement - Demonstrates initiative and critical thinking to identify, prioritize both process and performance gaps. Develops solutions and leads the team to deliver improving results. Serves as a leader to exemplify continuous improvement thought processes and focus.
- Team - Proactively manage performance and team dynamics to ensure that a fair, professional, and high-performance environment, aligned with company values is maintained. Commit to self-development, develop individual and organizational capabilities to build bench strength while delivering results now and into the future.
- Lead investigations tied to Non-Conformances, Complaints, and CAPA. Produce as team member or leader of investigative team as required for leadership or engineering technical assistance.
- Lead engineering actions identified though production visual management boards
- Source, plan, present, and deliver significant projects targeted at reducing waste, increasing productivity, and reducing stress on the operations and its operators. Demonstrate competency in the use of the tools of improvement - Six Sigma and Lean Tools associated with the team.
- Design / modify / fabricate tools and fixtures to support the needs of manufacturing and provide for improvement opportunities.
- Create and update manufacturing and engineering documentation (Work Instructions, SOPs, Specifications, Engineering Drawings, etc), and perform training as necessary.
- Demonstrated competence in process qualification and validation activity. This activity includes authoring and executing validation plans, engineering studies, Installation Qualification (IQ), Operational
- Qualification (OQ), Process Qualification (PQ), and Test Method Validation (TMV) in accordance with ISO, FDA and corporate guidelines.
- Keep track of industrial trends in applications and technologies, including practices and engineering tools. Maintain knowledge of technology changes to be able to implement in operations
- Support R&D activities as required utilizing technical skills to provide positive input to projects and to manage the transfer process from design to manufacturing. Ensure new platforms are capable of manufacturing in a cost-efficient manner.
- Demonstrate project management skills including but not limited to defining scope, identifying measurable results, methods and resources necessary for improvement, timeline management and capable results.
- Adhere to all Company policies, rules, procedures, and housekeeping standards.
EDUCATION / EXPERIENCE REQUIREMENTS :
Minimum 4-year degree in an Engineering discipline - Mechanical, Biomedical, Plastics, Industrial, etc.Manufacturing Engineering or equivalent experience required in a regulated environment. 2-3 Years minimum experience. 3 year minimum with an advanced degree.SPECIALIZED SKILLS & OTHER REQUIREMENTS :
Basic understanding and working experience of requirements applied to Manufacturing Engineering Concepts.Competence with tools of Lean / Six Sigma Concepts and Process.Capable of leading projects with operational results with minimal guidance.Competence in MS Office including MS Project and VisioExcellent verbal and written communication skills, including presentations (internal and external customers)Experience designing, validating, and implementing production fixturing and equipment is a plus.Experience with Solidworks is a plus.Must possess high degree of organizational skillsAbility to deliver superior results in team environmentsAbility to plan and prioritize activities for self and for others on teams supportedAbility to work independently to meet assigned project deadlines and assist others in meeting their target deadlines.If you are interested, please apply directly to this job posting!
Pay Details : $31.00 to $33.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer / Veterans / Disabled
Military connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and / or security clearance requirements, including, as applicable :
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance OrdinanceMassachusetts Candidates Only : It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.