Director, Operations Engineering - New Product Transition

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary Within the Infection Prevention Technologies (IPT) Operations team, the Director of Engineering plays a pivotal leadership role, overseeing and guiding a team of diversified engineers and engineering minded individuals who are focused on new product design transitions, encompassing prototype construction, sustaining engineering tasks, and providing support for our in-sourcing efforts across the IPT Operations division.
The Director will be expected to lead, interface, and influence others in various organizations within the company.
Requires working with R&D and manufacturing operations to support the strategy and development plans for a product pipeline.
Relies on experience and good judgment to plan and accomplish goals.
A wide degree of creativity and latitude is expected.
What You Will Do As the key liaison between R&D and Operations, facilitates communication and interaction among functional business heads to enable smooth transition for initial prototype/formulation, final manufacturing location, and scaleup as part of the NPD process.
Provides leadership and subject matter expertise to product development team to ensure product design is manufacturable at production scale upon transfer.
Ensure effective development phase collaboration with R&D/Operations through final prototype/formulation release on development requirements, process scaling inputs, process equipment/fixture development, work instruction development, method development, analysis tool development, internal and supplier material specification development, release specification development, BOM development, validation planning and execution, validation reporting, and packaging and labeling development.
Delivers critical, timely communications to the leadership.
Identifies critical dependences, risks, and contingency plans.
Proactively monitors progress, anticipating the effect of dependencies on schedule, cost, etc.
Oversee direction, planning, and performance of Design Transfer team and associated personnel.
Sets and communicates challenging expectations, provides support, leadership, and constructive feedback to staff members in support of meeting expectations while fostering growth and development.
Communicates and works with Planning to schedule pilot builds and initial production timeline.
Develop and lead implementations of strategic business plans to leverage resources and core competencies across manufacturing facilities which may include initiatives such as in-sourcing, relocation of processes, product transfers, and development of production lines.
Identify, prioritize, and manage sustaining engineering projects for improvement of manufacturing processes, test methods, product specifications, process/test equipment/fixtures, analysis tools, and business systems.
Drive prioritization, development, and implementation of basic product sustaining engineering activities; fulfill design transfer responsibilities for product sustaining engineering changes requiring product development cycle.
Maintain core knowledge of key equipment and infrastructure and assist with the capital budgeting process for IPT Operations including planning, standardization, and execution.
Evaluate high profile and/or high impact strategically important engineering projects and lead or support project management activities while fostering and maintaining communication and continuity of strategic direction.
Foster a continuous improvement culture and support LEAN initiatives 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.
Also responsible for ensuring that 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.
Responsible for managing the department budget and operating plans.
What You Need To Be Successful Bachelor’s degree in Mechanical / Electrical / Biomedical / Chemical Engineering required, Masters in Engineering Discipline, MBA preferred 10+ years of experience in manufacturing environment.
5+ years of experience managing / directing a department 10+ Years Capital Equipment/Consumable Products Experience (Defense, Aerospace, Medical Devices, Appliances) Strong project / program management skills required Proven expertise in leading a team of diversified engineers and engineering minded individuals responsible for New Product Design (NPD) insourcing and outsourcing, second sourcing, capital expenditure, and plant efficiency initiatives, consistently achieving successful outcomes.
Experience with new product introductions and/or in-sourcing initiatives Experience in LEAN Methodologies Experience in evaluating and purchasing capital equipment Experience in more than one of the following functional areas: Operations, Supply Chain, Quality desired PMP certification a plus What We Offer The opportunity to join a company that will invest in you for the long-term.
STERIS couldn’t be where it is today without our incredible people.
That’s why we share in our success together by rewarding you for your hard work.
Hiring people who are in it for the long run with STERIS is our ultimate goal.
We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid time off, holidays, matching 401(k), annual merit, and incentive plans.
Join us and help write our next chapter.
Competitive pay Annual merit bonus and incentive plans Medical, vision, prescription, dental and life insurance 401(k) with a company match Paid vacation time and paid holidays Tuition assistance Opportunities for advancement #LI-HT1 STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.
We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD.
STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.
If you need assistance completing the application process, please call 1 (440) 392.
7047.
This contact information is for accommodation inquiries only and cannot be used to check application status.
STERIS is an Equal Opportunity Employer.
We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.
We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
The full affirmative action program, absent the data metrics required by § 60-741.
44(k), shall be available to all employees and applicants for employment for inspection upon request.
The program may be obtained at your location’s HR Office during normal business hours.