Sr Engr

Pay range: $49-59/hr
*depending on experience

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems / procedures to optimize product development, internal and external device manufacturing, and device distribution.

Key Responsibilities:
• Investigate manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
• Conduct validation assessments for design / in-process inspection test methods and evaluate conformance to internal standards
• Identify opportunities for re-design / design of equipment, tools, fixtures, etc. to improve design test method / manufacturing inspection processes
• Support development of training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work
• Other incidental duties assigned by leadership

Education and Experience:
Bachelor's Degree in Engineering or Scientific field, 4 years related work experience required
or
Master's Degree or equivalent internship, senior projects or thesis experience in Engineering or Scientific field, plus 2 years related work experience required

Additional Skills:
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Understanding of statistical techniques (Gage R&R, control charts)
• Previous experience working with lab / industrial equipment required
• 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
• Experience adhering to Quality Systems requirements
• 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 communicate with 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