The Principal Operations Engineer provides process development support for R&D projects along with Manufacturing support for existing system production. This role utilizes design for manufacturing (DFMA) methods and tools to create processes and designs that are robust and able to be manufactured economically, leads projects which drive improved cost, quality and the continued supply of product for worldwide operations, and uses creativity and accepted engineering practices to design and develop creative engineering solutions for complex medical devices. This individual must manage multiple projects of varied scope, mentor junior engineers, and lead and provide work direction to Technicians.

PRIMARY DUTIES AND RESPONSIBILITIES:

Identifies released product design and manufacturing process issues, evaluates critical nature, determines root cause, develops design and process solutions, and implements solution.

Designs, develops, prototypes, measures, and tests mechanical hardware and consumables used in electro-mechanical, software controlled devices

Works cross-functionally to ensure design addresses internal & external supplier needs

Effectively utilizes broad knowledge of materials and manufacturing processes to create and maintain documentation suitable for regulatory submissions

Provides hands-on support for products from design and process development to commercial release and end of product life

Maintain skills and awareness of technical improvements and competition advancements

Rigorous documentation for all phases of projects, including design specifications, manufacturing requirements, verification test plans, qualifications, project schedules, drawings, and change orders associated with medical devices and consumable products.

Routine communication with peers and supervisors including documentation of work meetings, and decisions

Develops & maintain project plans, coordinates project activities, set/adhere to milestones, manage concurrent projects

Ensure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion

Direct outside contract personnel as needed for completion of specific tasks.

Provide work direction, coaching, and guidance to manufacturing technicians and junior engineers

Promote employee development and foster growth of employees through:

• Performance Management
• Skills development
• Continuous one-on-one feedback
• Bi-annual appraisal of individual performance
• Recognition and motivational techniques/tools to drive high levels of employee performance and engagement

Oversee and/or conduct training of new and existing employees and facilitate assimilation of new members and changes

Identify resource needs (human, equipment, etc.) and communicate to management for improvement as needed, addition of capabilities, and future growth projections to support a growing business.

Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation

Ensures product meet requirements regulated by FDA, UL, CE and other governing bodies

Participates in selection of vendors and fabrication sources to assure quality and compliance to released specifications

Required Skills

• BS in an engineering discipline

• 9+ years experience as a manufacturing engineer in a regulated industry

• Strong interpersonal and communication skills

• Technical writing skills

• Ability to prioritize and handle multiple tasks.

• Strong problem solving skills with the ability to interpret drawings, schematics, and specifications.

• Moderate to high level of computer proficiency including MS Office Suite, SolidWorks, ERP Systems

• Ability to assimilate technical concepts quickly and present technical information clearly and concisely for technical and non-technical audiences.

• Process development experience

Preferred:

• MS Manufacturing / Mechanical / Chemical Engineering

• Experience managing or leading others in a similar capacity, and/or demonstrated experience working cross-functionally in the engineering / test environment.

• 7+ years medical device experience

• Ability to coordinate multiple projects simultaneously

• Knowledge of QSR, ISO/EN and Quality System Standards

• Project management experience

• Experience implementing design changes with Contract Manufacturers

• Experience in process development and process improvement

• MDR related experience

Required Experience

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

KNOWLEDGE/SKILLS/ABILITIES

Demonstrated ability to handle multiple tasks simultaneously. Detailed oriented with excellent organizational skills. Good problem solving skills. Be able to identify product by size, type, style, color or product code. Ability to effectively communicate verbally and in writing. Solid reading skills – must be able to read orders/ match orders to delivery reports and picking labels. Basic math skills and reasoning skills. Basic proficiency in computer operating systems. Certification of power-truck equipment. Ability to understand and execute instructions. General understanding of the warehouse and footprint. Basic carpentry skills.

CORE COMPETENCIES

•  Job Knowledge •  Work Quality / Work Quantity •  Customer Focus •  Initiative / Decision Making / Judgement •  Communication / Active Listening •  Accountability / Integrity •  Interpersonal Skills / Team Oriented / Collaboration •  Emotional Stability / Adaptability •  Emotional Intelligence

WORKING ENVIRONMENT / PHYSICAL REQUIREMENTS

Work is performed in a warehouse environment, with some outdoor exposure during workday. It is a very active job and while performing the essential duties and responsibilities of this job, the associate:

•  Continuously stands, walks, bends, stoops, kneels, crouches, crawls, bends, climbs, grips, lifts, pulls, pushes and reaches above shoulder level throughout work shift, •  Uses regularly hands to finger, handle or feel or use power tools; reach with hands and arms; and talk and hear •  Lifts/moves objects up to 110 pounds, unassisted, and lifts/moves objects up to 150 pounds, assisted. •  Withstands temperatures in a typical warehouse environment, •  Uses specific vision abilities such as close vision, distance vision, peripheral vision, depth perception and ability to adjust focus. •  Uses and operates standard warehouse equipment/machinery such as hand trucks, box cutters.