Senior Manufacturing Engineer

7 days ago

Ham Lake, Minnesota, United States NACS, Inc. (now part of Ascential Medical & Life Sciences) Full time
Job Description

As a key member of our team at NACS, Inc. (now part of Ascential Medical & Life Sciences), we are seeking a highly skilled Senior Manufacturing Engineer to join our dynamic team. In this role, you will play a critical part in the development, qualification, and execution of medical device and industrial manufacturing processes.

Key Responsibilities:

  • Assist in the development and qualification of Medical Device and Industrial productions
  • Write detailed production documentation
  • Evaluate manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators
  • Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors
  • Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout
  • Assure product and process quality by designing testing methods; testing finished goods, determining product and process capabilities; establishing standards; confirming manufacturing processes
  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements
  • Prepare product and process reports by collecting, analyzing, and summarizing information and trends
  • Provide manufacturing engineering information by answering questions and requests
  • Maintain product and company reputation by complying with FDA, ISO9001 and ISO13485 regulations
  • Keep equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service
  • Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
  • Contribute to team efforts by accomplishing related results as needed
  • Develop statistical methods of quality control
  • Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions
  • Support validation in all manufacturing processes per FDA requirements for medical equipment
  • Conduct risk assessment on process steps and their ability to meet requirements
  • Create and maintain product assembly instructions
  • Establish preventive maintenance and calibration requirements for process fixturing / equipment
  • Identify opportunities for cost reduction; implement process and product improvements to achieve cost reduction goals
  • Ensure proper documentation is completed to meet quality systems requirements. Write and review validation protocols and reports applicable to new processes

Requirements:

  • Minimum of Bachelors Degree in Manufacturing Engineering or other relevant Engineering discipline
  • Dealing with Complexity, Informing Others, Leadership, Supervision, Hardware Specifications, Manufacturing Methods and Procedures, Manufacturing Quality, Product Development, and Presenting Technical Information
  • Knows and applies fundamental concepts, practices and procedures of a variety of manufacturing practices including lean manufacturing
  • Robust understanding of process validation concepts and practices including, IQ, DOE, OQ, PQ and PPQ
  • Basic understanding of ISO Quality System requirements and FDA regulations
  • Adept and experienced problem solver able to determine root cause of technical issues and implement effective solutions in a timely manner
  • Creative thinker with ability to think 'out of the box' in a fast-paced entrepreneurial environment
  • Demonstrated resourcefulness and ability to adapt to a variety of situations
  • Demonstrated ability to prioritize, initiate, and drive projects to completion
  • Solid knowledge of engineering fundamentals; ability to apply this knowledge to manufacturing and product
  • Strong attention to detail
  • Must be well organized
  • Must have strong documentation skills
  • Must have complete working knowledge of MS Office
  • Must have a good understanding of statistics
  • Must have basic mechanical design skills
  • Must have good written and verbal communication skills
  • Some light travel may be required

Education and/or Experience:

Typically requires a University Degree with 4-7 of relevant experience or an Advanced degree with a minimum of 2 years relevant experience

Reasoning Ability:

Must be able to foresee changing project schedules and adjust personal assignments accordingly. Ability to adapt to a rapidly changing work environment and still maintain department effectiveness

Physical Demands:

The physical demands described here are representative of those that must be met by an employee 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 duties of this job, the employee is regularly required to stand, sit, talk, walk, use hands, see, and hear. Drive to customer sites for meetings. Infrequent lifting of up to 25 pounds is required

Work Environment:

The work environment characteristics described here are representative of those an employee 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 environment is generally clean, and the noise level is moderate. Air is generally clean with occasional welding smoke or cleaning solvent smell. Production environment will include an ISO class 7 or 8 cleanroom

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