Senior R&D Engineer

ACIST Medical
7905 Fuller Road

Eden Prairie, MN

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Senior R&D Engineer

Position Description
As an integral member of the Research & Development team, the Senior R&D Engineer – Sustaining utilizes a variety of data to identify opportunities. This role will lead projects and implement 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 creation and management of 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 & 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 BMT 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 expectationsEnsures 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 employeesDaily ownership of product lines and processes
Works closely with assemblers and technicians (at BMT) 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
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
Provides recognition to others
Utilizes motivational techniques / tools to drive high levels of employee engagement and performance
Transfers knowledge and experiences to others
May perform some personnel functions, including identifying resource needs, hiring, on-boarding, performance evaluations, terminations, promotions and salary decisions
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):

Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by Bracco Medical Technologies/ACIST Medical Systems
B.S in Engineering or equivalent degree (i.e. Physics)
5 – 7 years relevant experience
4+ 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 Bracco Medical Technologies 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)

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

Job Location
7905 Fuller Road, Eden Prairie, Minnesota

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