Job Descriptions

Key Areas of Responsibility

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
• Project manage the introduction of new capital equipment and support the associated qualification and validation activities.
• Evaluate process layouts in terms of supporting new process integration while ensuring best utilization of floor space ensuring optimum process flow.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
• Support capital acquisition activities.
• Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
• Conduct MSA studies for new products and new processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Review and approval of validation documentation.

Qualifications Knowledge Skills

• B.S in Mechanical Engineering or related engineering discipline with up to 2 or more years’ experience
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• The individual should enjoy working in a fast paced, dynamic and results orientated team environment.
• Excellent Interpersonal Skills – able to express ideas and collaborate effectively with multidisciplinary teams.
• Innovative thinker – should be able to envisage new and better ways of doing things.
• Excellent analytical skills, ability to plan, organize and implement concurrent tasks.
• Good knowledge of manufacturing processes, materials, product and process design.
• Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
• Experience in an FDA regulated or regulated industry beneficial.

Skills

• Analytical Skills
• Problem Solving Skills
• Multitasking
• Self Starter
• Excellent interpersonal skills

Experience

• 2+