Sr Engineer

Duties:

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

Key Responsibilities:

• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards.
• Lead and establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Develop 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 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.
• 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.

Skills:

• Basic understanding of statistical techniques.
• Previous experience working with lab/industrial equipment required (if applicable).
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable).
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
• Strong problem-solving, organizational, analytical and critical thinking skills.
• Substantial understanding of processes and equipment used in assigned work.
• Good leadership skills and ability to influence change.
• 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 inter-departmental teams and key contact representing the organization on contracts or projects.
• Adhere to all EHS rules and requirements 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

Education and Experience:

• Bachelor's Degree (Preferably Mechanical, Industrial or Bio-Medical) in Engineering or Scientific field with, 4 years of experience including either industry or industry/education Required or Master's Degree or equivalent in Engineering or Scientific field with, 3 years of experience including either industry or industry/education Required or
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education Required.