Manufacturing Engineer II - Medical Device

RESOLUTION MEDICAL LLC•Minneapolis, MN

21h•Onsite

About The Position

The Manufacturing Engineer II position supports, improves, implements and sustains optimal, cost-effective and compliant manufacturing processes in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; coordinates manufacturing launch for new or revised products. Works with suppliers to ensure seamless transactions and proper understanding of requirements. This position will be focused on manufacturing engineering support within the clean room for products that are transitioning from NPI to Commercial Manufacturing.

Requirements

Bachelor’s degree in engineering or related and equivalent field experience
3+ years of Manufacturing/Sustaining experience in the medical device industry
Strong oral and written communication skills; customer focused
Experience with programs including SolidWorks and/or Mastercam
MS Office Proficiency
Problem solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner
Working knowledge and experience with Quality System regulations and guidelines ISO, FDA, and GMP
Ability to handle and be trusted with confidential and/or sensitive information.
Able to work in a fast-paced, constantly changing environment.
Ability to be flexible and to handle multiple projects in an organized, timely manner.
Able to problem-solve, work under pressure, and to effectively manage stress.
Ability to work overtime as needed.

Responsibilities

Designs and carries out process improvement, root cause problem solving, project management and employee training.
Aware of DFM and manufacturing robustness of process parameters for critical processes and repeatability
Applies engineering principles in managing, supporting, and maintaining the production of new and existing products and implementation of design changes and product improvements
Independently works with assignments and instructions as to the general results expected.
Generates engineering documentation (specifications, risk analysis, drawings, reports, protocols, revisions, etc.)
Improve manufacturing processes and methods for quality improvements, efficiency and capability improvements.
Prepares and presents detailed plans necessary to complete assigned projects. Develops schedule milestones, coordinates manpower, facility and equipment for assigned projects
Initiates the improvement of production controls, standard operating procedures, safety, quality control and training.
Develop manufacturing processes including production flow, assembly methods and production equipment.
Prepares and maintains detailed layouts of buildings and equipment.
Coordinates and manages the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results.
Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis.
Performs product/process analysis for production and quality metrics.
Represents manufacturing on cross-functional teams.
Write engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials
Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.

Benefits

Options for Medical, Dental and Vision insurance
Health Savings Account (requires participation in eligible medical plan)
Flexible Spending Accounts
Employee Life Insurance & Accidental Death & Dismemberment (AD&D)
Long Term Disability (LTD)
Kavira (requires participation in medical plan)
Employee Supplemental Life & AD&D
Spouse and Dependent Life & AD&D
Short Term Disability (STD)
Accident
Critical Illness
Hospital Indemnity
Employee Assistance Program
Flexible Time Off Program
Paid Parental Leave
Paid Holidays
401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.