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Title:  Engineer III, Manufacturing

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

PURPOSE OF POSITION:  The primary purpose of the job is to provide Manufacturing Engineering support to the Manufacturing department. The job contributes to the organization through development, implementation, and maintenance of manufacturing processes with compliance to regulatory requirements. Equipment complexity ranges from manual fixtures and jigs to fully automated assembly and test machines.

 

 

QUALIFICATIONS

 

Required:

  • Bachelor’s Degree in Mechanical, Industrial, Biomedical, or related Engineering from an accredited university.
  • A minimum of 4 years of manufacturing engineering experience; OR master’s degree plus 2 years’ experience.

 

Preferred:

  • Experience with medical device manufacturing and inspection technologies (heat staking, ultrasonic welding, press assembly, adhesives, leak testing, vision systems, and robotics, preferred).
  • Experience in medical device or similar regulated industry preferred. Experience in a high-volume manufacturing environment preferred, i.e. production 1M+ annual, cycle time < 3 second.

 

Skills & Competencies:

  • Understanding in Mechanical design fundamentals.
  • Ability to create experimental designs and collect, interpret, and analyze data using statistical techniques (Minitab preferred).
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).
  • Proficient with Solid Modeling for part and assembly creation (Solidworks strongly preferred).
  • Experience with spreadsheet and statistical analysis software packages (Excel and Minitab preferred).
  • Understanding of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation. Experience with the validation life cycle (planning, protocol writing, execution, report writing).
  • Must be able to work effectively on electrical, mechanical, and/or software related issues associated with equipment.
  • Strong analytical and creative problem-solving skills.
  • Excellent verbal communication skills.
  • Strong technical writing skills (planning, protocol writing, execution, report writing).
  • Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.
  • Demonstrated technical coaching and leadership of peers.

RESPONSIBILITIES

  • Support process design and optimization through design of experiments and engineering studies.
  • Support Manufacturing equipment specification, design, development, construction, implementation, debug, optimization, and modification.
  • Troubleshoot and implement solutions to aid in the manufacture of the product. Typical solutions require changes to assembly equipment and/or the modification of part/mold design and inspection criteria to improve the quality, reproducibility, efficiency or safety of the manufacturing processes.
  • Equipment Qualification (FAT, SAT, IOQ) to meet regulatory requirements. Create or execute test protocols to challenge equipment performance against intended specifications. Complete protocols and write validation reports.
  • Process Validation to meet regulatory requirements.  Includes writing protocols, execution of the protocol, and writing the validation report (OQ, PQ, PPQ).
  • Standard Operating Procedures creation, revision and implementation including necessary change order, operator training and verification activities.
  • Support the development of test methods and fixtures to prove functionality of sub-assemblies and final product.  Implement appropriate test methods and analyze test data to challenge the effectiveness of assembly equipment and processes.
  • Resolve internal and external (customer or supplier) issues related to manufacturability and performance of product.
  • Apply engineering principles and methods to understand and provide solutions to complex technical challenges.
  • Maintain and repair equipment.
  • Author Quality System documentation to support all of the responsibilities above, including but not limited to change control, engineering change orders, equipment forms, calibration forms, and preventive maintenance forms.
  • Provide project status to leadership.
  • Contributes to project planning and execution to meet schedule and budget requirements.
  • Author Quality System documentation to support all of the responsibilities above, including but not limited to change control, engineering change orders, equipment forms, calibration forms, and preventive maintenance forms.

 

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.