Project Engineer II

Posted 2 Months Ago
Be an Early Applicant
Devens, MA, USA
In-Office
70K-115K 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 leader in providing innovative manufacturing solutions to the medical device industry, with locations around the world. Our success is built on talented people who are passionate about speed, technology, quality, and exceptional performance. Backed by decades of manufacturing expertise and a commitment to continuous improvement, we continue to experience strong growth and offer exciting career opportunities for individuals who are ready to make an impact.

Job Summary

As a Project Engineer II, you will play a key role in the successful development and launch of new medical device manufacturing programs. Working closely with cross-functional teams and customers, you will lead projects from quotation support and concept development through mold and equipment validation, process development, and transfer to manufacturing. This position requires strong technical expertise, project management skills, and a hands-on approach to developing robust molding, automation, and assembly processes that ensure successful product commercialization.

Essential Qualifications
  • Bachelor of Science degree in Plastics Engineering, Mechanical Engineering, Automation Engineering, and a minimum of 2-3 years of relevant experience.
  • Strong interpersonal, verbal, and written communication skills.
  • Experience implementing scientific molding techniques, including decoupled molding processes.
  • Technical expertise in manufacturing processes and methods, including workflow optimization, equipment selection, production layouts, automation, and assembly operations.
  • Experience supporting new product development (NPD) activities from concept through commercialization.
  • Ability to organize, prioritize, and manage multiple projects simultaneously.
  • Demonstrated ability to work effectively in a collaborative team environment.
  • Excellent analytical and problem-solving skills with strong attention to detail.
  • Working knowledge of 3D CAD software.
Preferred Qualifications
  • SolidWorks experience.
  • Previous leadership or project leadership experience.
  • Experience within the medical device manufacturing industry.
  • Knowledge of Lean Manufacturing principles and continuous improvement methodologies.
  • Experience supporting new product introduction (NPI) and product launch activities.
  • Experience developing, validating, or supporting automated and/or manual assembly processes.
  • Familiarity with medical device assembly equipment, fixture design, and process validation activities.
  • Experience working with highly regulated manufacturing environments.

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).
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: 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

Similar Jobs

SMC Ltd Logo SMC Ltd

Project Engineer

Healthtech • Manufacturing
In-Office
Devens, MA, USA
1795 Employees
70K-115K Annually
In-Office
Hyannis, Barnstable Town, MA, USA
494 Employees

Takeda Logo Takeda

Engineer IV, Complaint Analyst

Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Hybrid
Lexington, MA, USA
50000 Employees
104K-163K Annually

Takeda Logo Takeda

Director, Global Marketing GI Oncology (New Product Planning)

Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Hybrid
Boston, MA, USA
50000 Employees
177K-278K Annually

Similar Companies Hiring

Rosendin Thumbnail
Other • Manufacturing
San Jose, CA
6219 Employees
Amalgamated Sugar Thumbnail
Food • Greentech • Agriculture • Industrial • Manufacturing
Boise, Idaho
768 Employees
Vitalize Thumbnail
Artificial Intelligence • Healthtech • Software
US
50 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account