ISC Engineering, Staff Engineer Equipment

bdx; Warwick (RI); On-site; USD 120,000 - 160,000; Full time

Job summary

BD is seeking an experienced engineer to lead assembly and equipment design, and to implement processes that align equipment design with business goals. The role requires extensive experience in automated manufacturing and a strong background in GMP/ISO environments.

You will manage design, vendor coordination, testing, and integration of new equipment, while mentoring engineers and ensuring safety, quality, and cost targets are met.

Qualifications

• Bachelor of Science in Engineering required.
• Minimum 12 years engineering experience in automated manufacturing.
• Experience with GMP/ISO and Lean Manufacturing desired.
• Experience in an FDA regulated quality environment desired.

Responsibilities

• Oversee the specification, quoting, sourcing and build of equipment refurbishments and new equipment lines.
• Lead equipment design reviews, risk assessments, and FMEA to ensure reliability and safety.
• Collaborate with procurement and legal on vendor contracts and supplier selections.
• Ensure equipment designs meet safety, quality, and manufacturability standards.
• Create and maintain 3D models and 2D drawings of components using CAD software.

Skills

Problem solving

Data analysis

Project management

Communication

Education

Bachelor of Science in Engineering

Tools

AutoCAD

SolidWorks

Job description

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

This position is responsible for Assembly & Equipment Design and Process Implementation and is positioned to ensure that the company's equipment design, supply, cost, etc. are aligned to business expectations. This position provides expert engineering skill, judgement, and mentoring to engineers and team members. This role will oversee the specification, quoting, sourcing and build of equipment refurbishments as well as new equipment and lines to support the business needs.

RESPONSIBILITIES:

Process & Equipment Development (Quality, Efficiency and Harmonization):

• Responsible for the generation of the user requirements specifications (URS) design (mechanical and/or electrical) and build of assembly and/or packaging equipment.

• Captures process performance from sites and create capital appropriation documents to support development of a capital request.

• Manage the integration of new equipmentthroughSATcompletion, and support EquipmentIntegration during install, FAT and startup. Implement Process Design on new equipment and ensure product designs are being met.

• Provide feedback and validate that the equipment design meets safety and operational standards basedon experience and validation from respective stakeholders.

• Leads suppliers and external design teams (vendor) for larger capital projects to manage cost, lead time and scope.

• Partnerships with procurement for vendor selection.

• Responsible for vendor contracts in collaboration with procurement and legal.

• Develop innovative concepts for mechanical systems and equipment based on projectrequirements, industry trends, and standard methodologies.

• Create, or obtain from the vendor,detailed 3D models/2D drawings of mechanical components and assemblies using CAD software.

• Create and maintain design documentation, including user requirement specifications, assemblyinstructions, bill of process, etc.

• Optimize equipment designs to minimize production costsand changeover time, simplify assemblyprocesses, design from theoperator’sstandpoint, maintainability,and ensure manufacturability.

• Participate in equipment design reviews, risk assessments, and continue to build failure mode and effectsanalysis (FMEA) to ensure reliability, safety, performance of mechanical systems/equipment.

• Collaborates with manufacturing teams to build and test prototypes of mechanical systems and components, gathering feedback, iterating on design as necessary.

• Perform various engineering analyses / simulation (i.e.stress, strain, thermal, fluid dynamics) tovalidate and optimize design.

• Work closely with other engineering fields and Maintenance teams. (i.e.electrical/mechanical engineers) to ensureseamless integration of mechanical systems with other project components.

• Comply with all local, state, federal, and BD safety regulations, policies, and procedures.

• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

• Other duties as assigned.

Minimum Experience:

• Works under general direction. Independently determines and develops approach to solutions.

• Tooling design experience of complex mechanical systems is desired

• Experience with PLC programming and Controls

• Proficiency in Autocad and/or SolidWorks is desired

• Excellent technical skills including project management, organization, planning, and capital budgets relating to mold procurement and verification.

• Demonstrated ability to apply problem solving and data analysis methods.

• Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts desired.

• Experience in an FDA regulated quality environment desired.

• Willingness and ability to travel domestically and internationally up to 25% average annually.

• Experience leading projects end to end.

• Strong communication skills

• Risk analysis / FMEA

• Statistical analysis / SPC system

• Ability to manage multiple conflicting priorities, and to develop and maintain tool qualification schedules.

Physical requirement:

• Ability to use a laptop/computer for extended periods of time (up to 8 hours)

• Ability to sit for long periods of time (up to 8 hours) in virtual and/or on-site meetings

• Ability to stand for long periods of time (up to 8 hours) when conducting FAT, SAT, on-site equipment/process troubleshooting, etc.

• Ability to climb steps, squat, etc.

• Ability to work independently in High Volume manufacturing floor

• Follow Safety and Quality/GMP requirements for medical device manufacturing site (Safety shoes, safety glasses, hair net, beard net, face mask, hard hat, etc….as required per manufacturing site)

POSITION REQUIREMENTS (AS APPLICABLE):

EDUCATION:

• Bachelor of Science degree in Engineering (chemical, mechanical, electrical or similar) required Appropriate equivalent hands-on experience and years of service also equally considered on a case-by-case basis.

EXPERIENCE:

• A minimum of 12 years engineering experience. Preferred background is in automated manufacturing equipment, with process development in high volume manufacturing. Experience with medical devices, in-vitro diagnostic and pharmaceutical products are a plus.

• Experience implementing process improvements and launching new equipment into a manufacturing environment. Comprehensive understanding of all phases of projects; brainstorming, scoping, budgeting, writing specifications, quoting, capital proposals, vendor management, coordinating installations, running validations.

• Experience with label printing and barcode specifications and requirements, as well as packaging cost analysis.

SPECIAL SKILLS:

• Proficient in CAD, WORD, Excel, MS Project. Working knowledge of Minitab is a plus.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA RI - Warwick

Additional Locations

Work Shift