Manufacturing Engineer 2, Boulder CO

SUMMARY:

As part of the Operations Team, this position is responsible for technically managing existing products and transitioning new products into Operations. Duties include but are not limited to: assisting in or leading component sourcing, working with vendors on technical issues, evaluating and procuring assembly equipment, designing and building fixtures and test equipment, conducting test method validations, validating processes, writing and training assembly instructions and providing clear records of such activities as established in procedures, protocols and other objectives.

 Performs job functions in accordance with company QSP, Financial, and Safety Procedures.

All successful candidates will work within 21CFR820, ISO (including applicable regional and sub-ISO standards) and Sarbanes Oxley compliant systems. Additional regulations and standards may apply.

 DUTIES AND RESPONSIBILITIES:

• Develop and implement Operations procedures, processes and technological solutions to meet product line cost targets for existing products. Partner with Product Development to do the same for new products.
• Write and conduct (as appropriate) Work Instructions, PM Plans, Engineering Studies, qualifications and process validations (IQ, OQ, PQ). and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Use statistical techniques to measure, evaluate, and optimize raw components, assemblies, finished goods and operations processes (GR&R, SPC, Capability analysis, DOE, etc).
• Manage Non-Conforming Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs) and aid in complaint investigations from beginning to end.
• Participate in lean manufacturing initiatives
• Update drawings, specifications, procedures, literature, etc, through Change Control methods.
• Partner with Quality to ensure all manufacturing deliverables comply with Encision’s QMS.
• Develop and conduct preventive maintenance and calibration of equipment as required.
• Travel as needed to conduct the duties and responsibilities identified. Level of travel is expected to be low.

 QUALIFICATIONS:

• A Bachelors of Science in Engineering, preferably in Mechanical or Industrial Engineering
• 5+ years’ experience in medical device manufacturing under 21CFR820 and ISO13485
• Applied statistics training and experience
• Solid Works training and experience
• Work with minimum oversight
• Ability to develop expertise in relevant medical device legal and regulatory requirements, as defined in the Encision Quality Manual, is required.
• Ability to read and comprehend instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations, all in English.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization (as appropriate) in English.

 COMPETENCIES:

• Healthy sense of urgency
• Effective time management, task and priority prioritization
• Excellent problem solving skills from initiation to completion
• Ability to weigh costs vs. benefits of methodologies and solutions
• Expert Microsoft Word and Excel skills
• Work with minimal supervision
• Expertise in relevant medical device legal and regulatory requirements, as defined in the Encision Quality Manual, is required.
• Ability to read and comprehend instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations, all in English.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization (as appropriate) in English.

PHYSICAL DEMANDS:

The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to finger, handle, feel, and be able to talk, and hear. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus. The employee is frequently required to lift and/or move up to 50 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.