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Lead Manufacturing Engineer

Company: Scanlan International
Location: Saint Paul
Posted on: June 9, 2021

Job Description:

Surgical Technologies, Inc., a Scanlan company, has an exciting opportunity to join our team as a Lead Manufacturing Engineer!

STI has been a pioneer in medical contracting since 1981. Today, we continue as a leader, expanding our resources to better serve our customers. From the initial contact to the final development of products, we enforce rigid, industry leading standards. This commitment has earned STI an international reputation for dependable contract packaging, responsive service, and the ability to adapt to the ever-changing needs of the healthcare industry.

This position is based in St. Paul, MN.

SCHEDULE: Monday - Friday; 8:00am - 5:00pm.

PAY: Based on experience.

  • This position is not eligible for Visa sponsorship or relocation assistance.*

POSITION / JOB SUMMARY:

The Lead Manufacturing Engineer (LME) oversees the development and implementation of manufacturing processes to maintain proper product functionality as well as cost efficiency; is responsible for the development of manufacturing equipment; and may supervise assigned manufacturing engineers and engineering technicians. The LME will evaluate, investigate, plan, manage and lead projects to onboard new contract manufacturing customers for the Company and manage other projects as assigned. The LME will manage the execution of the applicable processes, like Customer Change Request and Request for Quote, to deliver projects on time and within established budget. The LME must demonstrate clear project leadership to drive results from a multi-function team. The LME must demonstrate excellent relationship skills, including customer-facing interactions.

Position Responsibilities / Essential Functions:

Percentage Time

Accountability

30%

New Customer Onboarding/Project Management:

  • Manages the integration of new products (from existing customers) or new customers into the contract manufacturing organization.
  • Supports outside sales to qualify, estimate, develop quotations and perform any other tasks to acquire and onboard new products (from existing customers) or new customers.
  • Performs project management of cross-functional teams, planning, creating and executing Project Plans utilizing Gantt schedules, financial statements, project management processes & templates and other formats, as required.
  • Acts as an Engineering representative as needed with projects
  • Works with Customer Service, Manufacturing Engineering, Operations, Purchasing, Logistics, Finance and Quality Assurance to develop solutions for the onboarding of new customer products and processes.
  • Supervise assigned engineers and engineering technicians, as pertaining to New Customer Onboarding.
  • Assists with the development or acquisition of new technology to support sales strategies to attract new customers.
  • Assists in new product (from existing customers) or new customer business-case analysis.
  • Responsible for new product and customer onboarding process and continuous improvement.
  • Assists in the development of strategy and tactics

40%

Sustaining Engineering:

  • Supervise assigned engineers and engineering technicians, as pertaining to Sustaining Engineering.
  • Prepare and deliver performance reviews, annual goals and merit reviews.
  • Analyze and design lean manufacturing cells using effective systems and simulation tools to provide optimization, use of space, equipment, material and personnel.
  • Assist, support and implement manufacturing processes in accordance with applicable medical device regulations and other applicable regulations.
  • Ensure that products are manufactured at the highest quality levels.
  • Champion Lean principles, providing leadership and Lean training.
  • Lead cost reduction and capacity expansion projects.
  • Assist in developing plant layout in planning rearrangement of facilities, equipment and operations for better utilization of space.
  • Ensure all manufacturing safety regulatory policies and procedures are implemented and maintained at all times.
  • Determine and eliminate root causes to address process problems. Support the CAPA/NCMR/Complaint processes.
  • Develop and implement manufacturing processes in accordance with internal and customer-supplied specifications, following applicable standards, test protocols vendors/subcontractors.
  • Perform those tasks as assigned by supervisor.

30%

Technical Services

  • Manages the Technical Services function, directing and coordinating tasks as necessary to cross-functional participants.
  • Responsible for and continuously improvement of the Customer Change Requests (CCR) process, defining CCR scope, schedule and budget.
  • Works with external customers to understand changes and establishes the scope of change
  • Works with the internal/external teams to establish change management strategies
  • Produces customer proposals, including statements of work (SOW)
  • Works with Finance to determine Proposal NRE pricing.
  • Reports monthly on Technical Services KPIs and revenue

QUALIFICATIONS:

Required Qualifications:

Education:

  • Engineering Degree(or equivalent relevant industry experience).

Experience:

  • 7+ years' experience in a Medical Device company (FDA/ISO 13485) required, preferably a contract manufacturer.
  • 3-5 years' supervision of engineering associates.
  • Engineering project management.

Skills:

  • Intermediate to advanced proficiency with Microsoft Outlook, Word, Excel, PowerPoint and Project, and with a Pro/E or SolidWorks design application software.
  • Strong analytical and technical skills.
  • Sound business judgment.
  • Effective written and oral communication skills.
  • Strong strategic/visionary skills - can clearly articulate their vision for the project.
  • Team player.
  • Energetic, self-motivated and can work independently.

Preferred Qualifications:

  • Lean certifications.

Physical Demands

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job, the associate is regularly required to stand, walk, sit and use hands to manipulate, handle, or feel objects, tools, controls and office equipment. The associate frequently is required to talk and hear. The associate must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

Work Environment

The work environment characteristics described herein are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually very quiet.

Surgical Technologies, Inc. has an excellent benefit package to include:

  • Medica Health Insurance (9 different plan options)
  • Health Savings Account (HSA)
  • Company paid Dental Insurance
  • Company paid Life & Disability Insurance
  • Vision Insurance
  • 401K with Company match
  • Tuition Reimbursement Program
  • Training / Development Program
  • Paid Time Off
  • Holiday Pay
  • Employee Assistance Program

Apply today to join our team!

Keywords: Scanlan International, St. Paul , Lead Manufacturing Engineer, Other , Saint Paul, Minnesota

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