STERIS · 9 hours ago
Engineering Project Manager
STERIS is a company that provides innovative healthcare and life science product and service solutions. The Engineering Project Manager is responsible for managing multiple medical device new product development projects, ensuring alignment with company strategy and compliance with FDA/ISO requirements.
BiotechnologyHealth CareMedical Device
Responsibilities
Work with Product Managers, Sales Team, Product Specialists, Manufacturing and Engineers in creating design and manufacturability process validation plans and lab tests. Attends CFT market research sessions when appropriate
Leads and drives the planning and implementation of multiple repair/NPD projects, varying in size and scope and recommends revisions in project work plans as appropriate to meet changing needs and requirements
Assembles Cross Functional Teams (CFT) and leads them through the development process for projects of varying complexity, including new medical devices and services
Identifies and defines resource requirements needed and recommends assignments for individual CFT member responsibilities
Facilitates the definition of projects’ scope, goals and deliverables
Manages day-to-day operational aspects of projects and scopes
Leads Voice of Customer initiatives and works closely with Product Management to define customer/market requirements for new products development
Works with supervisor in managing project resource allocations across all projects
Works with various department heads to assure alignment of CFT member objectives and work schedules to assure projects deliverables are achieved
Effectively applies Stage/Gate methodology and enforce project standards to drive project completion
Leads and manages creation of Gate deliverables and Gate presentations with project team and senior management
Ensures project documents and Gate deliverables are complete, up-to-date, and stored appropriately
Assists in identifying project risks and critical issues and developing applicable mitigation plans to minimize exposure on projects
Suggests areas for improvement in internal processes along with possible solutions
Prepares and presents reports defining project progress, problems and solutions for management, as needed
Implements and manages project changes and interventions to achieve project outputs
Complies with and helps to enforce standard New Product Development policies and procedures
Work with CFTs to develop project schedules and tracks project deliverables to completion
Leads and coordinates market release inventory requirements with Supply Chain and Materials/Logistics departments
Work with Quality, Regulatory, and Document Control to ensure all project documentation requirements are fulfilled for product release
Provides input and leads design/documentation review meetings
Develops and manages budgets for the project including resource loading, external expenses and capital requirements
Actively seeks collaboration and builds relationships with internal customers and external partners to improve overall outcomes and timely project completion
Qualification
Required
Bachelor's degree with 5+ year's successful demonstrated experience managing complex new product development projects is required
Technical degree in the sciences or engineering fields highly beneficial
Demonstrated planning and organizational skills with background and experience in Design Control and Stage Gate methods is required
Must be a proficient user of Microsoft Project (or similar), Excel, Power Point, Visio, and Word
Possess ability to conduct market research via internet
Up to 15% domestic travel is required
Preferred
Project Management
Team Leadership
Coaching
Communication Competency
General Business Acumen
Extremely Analytical
Strong Problem Solving and Critical Thinking
Decision Making
Well Developed Interpersonal Skills
Conflict Management
Outstanding Written and Oral Communication
Teamwork
Project Management Professional (PMP) or New Product Development Professional (NPDP) certification(s) a plus
Experience with FDA guidance, ISO 13485 regulations and CE Mark requirements is highly preferred
Experience with Medical Device development is highly desired
Benefits
Competitive Pay
Extensive Paid Time Off and (9) added Holidays.
Excellent healthcare, dental, and vision benefits
401(k) with a company match
Long/Short term disability coverage
Parental Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Continued training and educations programs
Excellent opportunities for advancement in a stable long-term career
Company
STERIS
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
H1B Sponsorship
STERIS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (28)
2023 (15)
2022 (33)
2021 (18)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$0.28M2010-05-21Post Ipo Debt· $0.28M
1998-12-01IPO
Leadership Team
Recent News
2025-11-05
Company data provided by crunchbase