Global Lead Sustaining Engineer
Apply NowCompany: Cook Group
Location: Bloomington, IN 47401
Description:
Overview
Lead Engineer, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. The Lead Engineer works independently with limited oversight and manages complex/difficult technical projects or processes that have a major impact on departmental results. The Lead Engineer acts as a mentor and leader in the department and reviews work outputs of less experienced engineers/contractors in the department, delegating work as necessary to achieve departmental goals.
Responsibilities
- Lead and influence discussions within team/department and with other functional personnel (Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors, and physicians) as necessary to progress projects/tasks.
- Efficiently manages multiple project/task timelines, resources and responsibilities to achieve team, departmental, and company goals.
- Identify and escalate problems/obstacles to appropriate level of management and implement possible solutions as necessary. Works with other team members to provide problem-solving guidance. Utilizes broad and deep experience strategically to inform project/task decisions.
- Presents project/task status updates clearly to team members and team lead/manager. May also present to global functional leaders/executives as necessary.
- Provide guidance and assistance to technicians or newer engineering employees/co-ops/interns/contractors. May review and approve outputs as necessary. Delegates appropriate tasks and follows-up on completion.
- Demonstrates deep design and risk knowledge of relevant product lines including process and regulatory details. Recognized as company expert for relevant product lines.
- Projects may include system or program level activities, providing overall guidance and leadership and delegating tasks as appropriate. Projects may affect multiple departments and/or global manufacturing entities.
- Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable.
- Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.
Qualifications
- Minimum 7 years engineering experience in a regulated industry, preferably in a medical manufacturing environment. Advanced degrees may reduce the experience requirement by 1-2 years. Project management experience preferred.
- Bachelor's degree in Engineering or Engineering Technology or related discipline.
- Familiarity with statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and demonstrated problem solving experience.
- Experience in communication and working with a wide variety of associates.
- Experience working independently and directing others towards a common goal.
- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Engineering Server, Business Objects.
Physical Requirements:
Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit for extended periods of time, stand, walk, and communicate.
- Personal protective equipment including safety glasses, lab coat and gloves may be required in some areas associated with this position.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
Lead Engineer, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. The Lead Engineer works independently with limited oversight and manages complex/difficult technical projects or processes that have a major impact on departmental results. The Lead Engineer acts as a mentor and leader in the department and reviews work outputs of less experienced engineers/contractors in the department, delegating work as necessary to achieve departmental goals.
Responsibilities
- Lead and influence discussions within team/department and with other functional personnel (Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors, and physicians) as necessary to progress projects/tasks.
- Efficiently manages multiple project/task timelines, resources and responsibilities to achieve team, departmental, and company goals.
- Identify and escalate problems/obstacles to appropriate level of management and implement possible solutions as necessary. Works with other team members to provide problem-solving guidance. Utilizes broad and deep experience strategically to inform project/task decisions.
- Presents project/task status updates clearly to team members and team lead/manager. May also present to global functional leaders/executives as necessary.
- Provide guidance and assistance to technicians or newer engineering employees/co-ops/interns/contractors. May review and approve outputs as necessary. Delegates appropriate tasks and follows-up on completion.
- Demonstrates deep design and risk knowledge of relevant product lines including process and regulatory details. Recognized as company expert for relevant product lines.
- Projects may include system or program level activities, providing overall guidance and leadership and delegating tasks as appropriate. Projects may affect multiple departments and/or global manufacturing entities.
- Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable.
- Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.
Qualifications
- Minimum 7 years engineering experience in a regulated industry, preferably in a medical manufacturing environment. Advanced degrees may reduce the experience requirement by 1-2 years. Project management experience preferred.
- Bachelor's degree in Engineering or Engineering Technology or related discipline.
- Familiarity with statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and demonstrated problem solving experience.
- Experience in communication and working with a wide variety of associates.
- Experience working independently and directing others towards a common goal.
- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Engineering Server, Business Objects.
Physical Requirements:
Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit for extended periods of time, stand, walk, and communicate.
- Personal protective equipment including safety glasses, lab coat and gloves may be required in some areas associated with this position.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.