Job Description Summary

Job Description

Role Purpose

Applies knowledge of technical principles and systems/procedures to optimize manufacturing processes.

Job Functions

Optimize manufacturing processes, including using engineering methods (e.g., SIX

Sigma and LEAN methods) for continuous process improvement and/or re-

design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills.

Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.

Analyze and resolve moderately complex Manufacturing and Compliance issues

(e.g., CAPA, non-conformances, audit observations).

Develop training and documentation materials (e.g., work instructions) for

production to enable the seamless knowledge transfer of project and manufacturing processes.

Establish project plans to ensure deliverables are completed to customer’s

expectations, using project management tools (e.g., Project Plan, Risk Analysis,

etc.)

Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.

Other incidental duties assigned by Leadership

Education/Experience

Engineering or Scientific field

2+ years experience

Master's Degree or equivalent, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education

Required Skills

• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

• Basic understanding of statistical techniques

• Previous experience working with lab/industrial equipment required (if applicable)

• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

• Solid problem-solving, organizational, analytical and critical thinking skills

• Solid understanding of processes and equipment used in assigned work

• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Knowledge of applicable FDA regulations for medical device industry

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders

• Ability to build productive internal/external working relationships

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift