Project Engineer II

Posted 2 Days Ago
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Devens, MA, USA
In-Office
70K-100K Annually
Junior
Healthtech • Manufacturing
The Role
Lead development of new medical device manufacturing projects from quotation through mold/tooling design, process development, validation, and transfer to production. Manage timelines, customer deliverables, testing/DOE, validation reports, and Device Master Record (DMR) creation. Provide technical support post-release and ensure compliance with engineering standards, safety, and quality requirements.
Summary Generated by Built In
 

About Us:

SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people





Job Summary:   

Participate in the development of new projects with the SMC project team from quotation support, through development and validation of molds, equipment, and manufacturing processes, and successful transfer to manufacturing.

Essential Job Duties and Responsibilities:

  • Work with internal / external resources to research, design, and develop the necessary elements of project molds, tooling, processes, automation, fixtures, End of Arm Tool (EOAT), and secondary equipment. 
  • Develop project timelines that support our quoted lead-times, and incorporate the customer requirements for validation, pilot builds, and approval. 
  • Manage projects to ensure customer deliverables to meet quality and financial requirements. 
  • Deploy good project management techniques with internal and external teams Act as a technical resource to the customer. 
  • Review product design for compliance with engineering principles/ standards and ensure adherence to customer requirements /specifications. 
  • Provide technical support and input in the areas of product design, material selection, mold design, manufacturing, secondary operations, validations and other areas related to our industry. 
  • Ensure mold, process, or assembly testing is performed in an appropriate to provide a thorough development, and a robust manufacturing process. 
  • Determine testing and Design of Experiments (DOE) objectives and resolve any issues found. 
  • Write /review validation reports and summaries related to the project.  Develop the Device Master Record (DMR), and ensure internal documentation and systems are current at the time of the Release to Manufacturing (RTM). 
  • Provide internal support for the project after RTM, and problem solve as needed.
  • Ensure a safe work environment by following all company safety policies and procedures. 
  • Perform all other duties assigned.

Essential Qualifications:

  • Bachelor of Science Degree in Plastics Engineering, Mechanical Engineering, or Automation Engineering, and 2 years related experience OR a two-year post High School diploma and 6 years related experience.  
  • Demonstrated effective interpersonal and communication skills, including written communication.
  • Experience implementing decoupled molding processes and scientific molding techniques.
  • Technical skills in manufacturing processes and methods including workflow, layout, assembly and production equipment.
  • Ability to organize, prioritize and manage multiple projects.
  • Demonstrated team player 
  • Excellent problem-solving skills with attention to detail.
  • Demonstrated problem solving skills.
  • Working knowledge of 3D CAD software. 

 

Desirable Qualifications:

  • SolidWorks experience
  • Previous leadership experience.
  • Experience within the medical device industry.
  • Previous experience with lean manufacturing concepts.

ADA Requirements:

  • Typically sits, grasps items and performs keyboarding for frequent operation of a computer
  • Stand, walk, bend, reach or otherwise move about occasionally
  • Lift, move or otherwise transfer items up to 30 lbs. occasionally
  • Occasional exposure to typical machine shop physical hazards
  • Travel by air or car occasionally

What SMC has to offer?

  • Clean, Climate-Controlled Environment
  • Stable schedule 
  • Paid holiday and PTO
  • Health, dental, and vision insurance
  • 401(k) retirement savings
  • Life and disability insurance
  • Promotional opportunities
  • Training and career growth programs
  • Amazing co-workers
  • Tuition reimbursement
  • Employee Assistance Program

 

We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.


At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job.  If your experience is close to what you see listed here, please still consider applying.  We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions.  Please let us know if you require reasonable accommodations during the interview process. 

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

#IND

#LI-SH1

Skills Required

  • Bachelor of Science in Plastics, Mechanical, or Automation Engineering with 2 years related experience (or two-year post-high school diploma with 6 years related experience).
  • Demonstrated effective interpersonal and written communication skills.
  • Experience implementing decoupled molding processes and scientific molding techniques.
  • Technical skills in manufacturing processes and methods including workflow, layout, assembly and production equipment.
  • Ability to organize, prioritize and manage multiple projects.
  • Demonstrated team player.
  • Excellent problem-solving skills with attention to detail.
  • Working knowledge of 3D CAD software.
  • Experience defining testing objectives and Design of Experiments (DOE) and resolving issues.
  • Ability to write/review validation reports and develop Device Master Record (DMR).
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The Company
Somerset, Wisconsin
1,795 Employees
Year Founded: 1988

What We Do

SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries. Services include design, engineering, thermoplastic molding including insert, two-shot and micro, liquid silicone injection molding (LIM) and complete device assembly. Project integration, supply chain management, validation, packaging and labeling, and sterilization responsibility are systematically controlled. Facilities offer ISO 13485, quality systems, white room, class 7 and 8 clean rooms. SMC Group: Oval Medical Technologies, an SMC Ltd. company, is a medical device company developing in revolutionary autoinjector platforms. Oval’s unique approach allows for devices that are smaller, easier and safer to use than any other device currently available. Pharmaceutical partners can utilise Oval’s technology to deliver viscous formulations and sensitive biological drugs that would otherwise not be possible to deliver in current marketed injectable devices. Oval is able to tailor the technology for specific patient populations producing devices that are truly patient centric. www.ovalmedical.com

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