Manager, Engineering

Steris Corporation•Mentor, OH

8d•Onsite

About The Position

As a key member of the site leadership team, the Engineering Manager is responsible for people management, process development, functional competency development, and overall execution of the engineering program. This role is also responsible for managing the New Process Development design transfer program for the site and insourcing projects. The Engineering Manager is responsible for driving processes, building prototypes, providing R&D guidance/feedback for Manufacturing effectively, and must adhere to systems and controls to ensure compliance with quality standards. You will work with Program Managers in supporting new product development and sustaining engineering. As an Engineering Manager you must be familiar with various design concepts, practices, and procedures and rely on experience and good judgment to plan and accomplish goals. A wide degree of creativity and latitude is expected. Own success of the team – people, process, platforms.

Requirements

Bachelor’s Degree Chemical, Mechanical, Biochemical, or Industrial Engineering or related field
Minimum 10 years’ experience in Project Management, Engineering, and/or R&D with progressively more responsibility
Minimum 5 years direct leadership experience in the areas of Project Management, Engineering Management, or R&D Management
Experience in Medical Devices, Pharmaceutical, Aerospace, or other highly regulated industry
Experience developing, justifying, and executing Capital Projects
Experience with development lifecycle and stage gate development methods for new product launch
Experience managing engineers and other support positions
Proven record leading high-caliber projects with cross functional teams
Demonstrated proficiency in driving continuous improvement for performance. quality, time, and cost
Strong planning and organization skills

Nice To Haves

Experience with FDA, GMP, ASME, PED, CR, CE standards
Lean / Six Sigma Certification such as Green or Black Belt
Certified in Project Management such as PMP or equivalent
Experience leading insourcing projects

Responsibilities

Act as the primary interface between Manufacturing and R&D for products for both Healthcare and Life Science business units. Ensure designs are complete and manufacturing concerns are addressed before design transfer stage gate.
Develop and implement production and manufacturing processes to introduce new products into the Manufacturing Facilities. Ensure product design is manufacturable at a production scale.
Deliver critical, timely communications to the program leadership on product development and delivery. Identify critical dependences, risks, and contingency plans.
Proactively monitor progress, anticipating the effect of dependencies on schedule, cost, etc.
Identify and implement continuous improvements on multiple axes (Products, Technologies, Processes, Tools, Methods, and Functional Competencies).
Assess and develop associate training and education plans.
Develop and lead team to apply structured, technical problem-solving methodologies such as DMAIC, six sigma green belt/black belt, statistical data analysis, etc. to confirm root causes of problems.
Implement corrective and preventative actions to solve root causes and prevent recurrence, reduce variation, and drive improvement in quality and other key KPIs.
Serve as Subject Matter Expert (SME) providing deep technical insights into operations processes, including chemical and biological formulation, filling, packaging, and quality operations.
Employ key project management principles including establishing and tracking timelines, identifying, and mitigating risks, communicating across teams at all levels.
Drive culture of High-Performance teams in the department through strategic initiatives (functional competencies, performance management, talent management, process improvements).
Must ensure that employees have a safe working environment, report all injuries, hazards or potential hazards, follow appropriate work practices, use appropriate personal protective equipment when required, and follow established security procedures. Ensure employees under their supervision receive the necessary training on all applicable safety and security work practices and procedures.
Demonstrate a commitment to patient safety and product quality by maintaining compliance with all Quality Systems requirements. Fully adhere to all applicable FDA regulations, international guidelines, and company policies at all times.
Establish and promote a work environment amongst co-workers and direct reports that supports compliance with the Quality System and company policy.
Manage interactions with R&D, Manufacturing, suppliers, and consultants to assure engineering programs comply with designs and specifications.
Participate in the evaluation of technology opportunities which can result in new business, products, or technological advantage. Provide technical support to other company and corporate groups as required in assigned areas of responsibility.
Complete diligence on potential product transfers or development requirements for products or concepts transferred from other potential sources.