Why Join Bracco Medical Technologies?

We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way.  Each member of the Bracco Medical Technologies team has the power to make a difference......every day!

Position Description

The Sr. Mechanical Engineer is a technical operations engineering position that works as an integral member of the operations teams, utilizes data to identify opportunities, and leads projects and implements changes focused on improving product performance and reliability, product enhancements, component obsolescence, increasing capacity, process capability and meeting our commitments. This individual will nourish collaborative relationships, mentor and transfer knowledge and experience to others, contribute to the creation and management of the operations engineering budget, and may perform some personnel functions. All work will be done in accordance with Regulatory Requirements and Quality Management System.

Primary Duties and Responsibilities:

Operations Support & Product Development

• Performs work in accordance with Regulatory Requirements (i.e. FDA, MDR, UL, CE and other governing bodies) and Quality Management System (QMS), including development and maintenance of documentation
• Supports compliance to Regulatory Requirements
• Enhances and utilizes metrics to identify opportunities, prioritize, lead projects and implement necessary changes focused on; supporting daily production; improving product performance and reliability; product enhancements; component obsolescence, increasing capacity and process capability; reducing lead-times, scrap, rework and operating costs; enhancing customer experiences; and meeting our commitments
• Uses data, product application (use-cases), internal and external information, knowledge of healthcare and sound engineering judgment to make decisions
• Utilizes appropriate problem solving and continuous improvement tools
• Develops, maintains & communicates project plans, coordinates project activities, sets / adheres to milestones and action list
• Partners with cross-functional team to actively manage contract manufacturers and suppliers in support of business strategies
• Provides process & product line support from prototype to manufacturing (may occur at ACIST or at one of our global contract manufacturers), product end-of-life support and customer usage
• Supports daily manufacturing activities
• Works as an integral member of new product development teams, helps to define requirements, creates processes and test systems, identifies suppliers and ensures products meet customer and market expectations
• Ensures new product designs are resilient and manufacturing processes are capable
• Frequently acts as a key resource / subject matter expert (SME)
• Implements ergonomic processes to preserve a safe work environment for our employees
• Daily ownership of product lines and processes
• Works closely with assemblers and technicians (at ACIST) or with global contract manufacturers to provide guidance and share knowledge

Project Management and Documentation

• Rigorous documentation for all phases of projects, including design specifications, manufacturing requirements, verification test plans, qualifications, project schedules, drawings, and change orders associated with medical devices and consumable products.
• Routine communication with peers and supervisors including documentation of work, meetings, and decisions
• Develops & maintain project plans, coordinates project activities, set/adhere to milestones, manage concurrent projects
• Ensure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion
• Direct outside contract personnel as needed for completion of specific tasks.

People Leadership

• Works collaboratively with other departments (product development, supply chain, manufacturing, quality, customer support, field services, finance, suppliers, sales and marketing)
• Provides transparent communications and encourages active exchange of ideas and information
• Transfers knowledge and experiences to others
• Provides work direction to less-senior operations engineers and technicians
• Mentors, coaches and develops others
• Collaborates with others who have supplemental knowledge and skills required to complete projects
• May perform some personnel functions, including identifying resource needs, hiring, on-boarding, performance evaluations, terminations, promotions and salary decisions
• Provides recognition to others
• Utilizes motivational techniques / tools to drive high levels of employee engagement and performance
• Contributes to creation and managing operations engineering budget, plans for future resources (human, equipment, etc.), addition of capabilities and future growth projections to support a growing business

Qualifications (Knowledge, Skills & Abilities):

Minimum:

• B.S. in Engineering or equivalent degree (i.e. Physics)
• 5 – 7 years relevant experience
• 2+ years medical device experience
• Demonstrated continuous improvement experience
• Understand system requirements (i.e. GMP, QSR, GLP, CE, CSA, ISO, etc.)
• Passion and commitment to learn and improve to achieve personal and company goals
• Work collaboratively with all ACIST team members, including product development, supply chain, manufacturing, quality, customer support, field services, finance, sales and marketing
• Experience in project leadership (including writing and executing project plans) with flexible approach and ability to influence others
• Assertive self-starter with excellent organizational, interpersonal, critical thinking, verbal and written communication skills
• Use creativity and accepted engineering practices to design, develop, prototype, verify, validate and implement product and process improvements
• Familiarity with some manufacturing and secondary processes (i.e. sterilization, molding, machining, extruding, forming, welding)
• Ability to identify required data, collect, consolidate and analyze for assessment, decision making and reporting utilizing problem solving and continuous improvement methodologies (i.e. PDCA, DMAIC, A3, 8D)
• Knowledge of how to properly analyze data sets using statistical software (i.e. Minitab, JMP, LabVIEW, etc.)
• Ability to travel up to 25% (domestic and international)

Preferred

• Proven ability to mentor and develop technical team
• Agile / SAP (or similar documentation control / MRP systems)
• Experience supporting capital and / or consumable medical device products
• Experience working with medical device contract manufacturers
• Experience working with different global cultures
• Technical project management skills
• Experience implementing design changes with Contract Manufacturers
• Experience in process development and process improvement
• Experience in catheter manufacturing/ processes