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Manufacturing Engineer, Senior

2 weeks ago

St Paul, MN, United States Minnetronix Medical Full time
Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary:

Senior Manufacturing Engineers will work cross functionally to manage the production build of complex electro-mechanical medical devices. A Senior Manufacturing Engineer is responsible for the production build of multiple product lines. Their responsibilities include: new product introduction, pilot builds, production cell layout, production documentation, issue tracking and resolution, and continuous improvement.

Job Duties and Responsibilities:
  • Manage the production builds of multiple product lines, along with issues list, device improvements and changes.
  • Mentor other members of the Operations Engineering team in sound root cause analysis methodologies, process development and qualification techniques.
  • Work with development engineering to manage the transfer of new products into production.
  • Create and maintain production documentation such as build of materials, assembly and test procedures, part drawings, and engineering change orders.
  • Address all quality documentation needs for the product line and work with QA to address any quality issues or concerns.
  • Keep the production team informed of production status.
  • Developed and lead team goals of continuous improvement efforts.
  • Work directly with customers as needed.
  • Stay current with medical device requirements and maintain technical awareness of new and existing manufacturing processes and trends.
Qualifications and Requirements:
  • Bachelor's degree in an engineering, technical or scientific disciple. 6-9 Yrs experience; (MA + 3-6 yrs).
  • 6+ years manufacturing engineering experience in electronic-based manufacturing environment. Medical device highly preferred.
  • Demonstrated experience with regulated environments such as FDA QSR's, ISO13485 for medical devices and ISO 9001:2000.
  • Highly proficient at writing and editing production and other technical documents.
  • Strong interpersonal communication.
  • Strong analytical skills and problem solving ability.
  • Proficient knowledge of quality improvement tools and techniques.
  • Ability to work independently, function as a team member, and lead teams.
  • Demonstrated proficiency working with computers and the MS Suite.

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Working Condition

Must be authorized to work in the United States.

Compensation and Total Rewards Package

The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.