The individual in this position will be a Packaging subject matter expert (SME) to provide support for design, development, verification and validation of sterile medical device packaging (e.g. sterile barrier systems) under the Enterprise Cost-To-Win (eCTW) Program for the BD Specimen Management business.
Job Description
Works under general direction to guide design and development of sterile medical device packaging (e.g. sterile barrier systems) that are needed to meet the business' Enterprise Cost-To-Win (eCTW) objectives, covering a multitude of cost-savings and continuous improvement initiatives around device packaging and associated processes.
Act as Packaging subject matter expert on cross functional teams to drive Packaging strategy and alignment to best practices and at times will function in a project leadership role.
Design/Engineer robust and manufacturable packaging by drawing on a combination of experience, sound judgment, problem-solving skills, engineering first principles, advanced engineering methods and critical thinking.
Collaborate with Manufacturing and other associates across Specimen Management and the wider BD organization to propose, assess the feasibility of, and implement packaging design/material/processes through rigorous Design Control processes.
Independently determines and develops approach to solutions and presents results to peers and business leadership.
Drives creative, logic and risk-based approaches to resolve technical challenges and tradeoffs under business constraints including strong capacity for critical thinking and analysis.
Develop, write, and execute robust packaging test methods, test fixtures, measurement systems analysis, protocols, data analysis and reports for Engineering studies, Design Verification, Validation, material and component specifications.
Writes, implements, and leads hands-on benchtop studies, tolerance stack up analysis, design verification, validation, vendor interactions, material specifications, component specifications, troubleshooting and/or root-cause analysis to evaluate product packaging performance & improvements.
Performs data analysis using statistical tools, generates reports and presents recommendations to peers and business leaders.
Provides inputs for manufacturing sites in process validation, process capability issues, and customer issues.
Supports and at times lead material, packaging design and/or process changes to existing products by following design control processes and generating well-documented research and analyses records.
Demonstrate strong drive for results and clear accountability for successful and timely completion of designated tasks and projects.
Collects, records, reports, interprets, and analyzes data, presents results to peers and business leadership.
Provides advanced engineering skills and product packaging evaluation support to the platform towards building business cases for new opportunities.
Ensures compliance with BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.
Qualifications
Strength in scientific and engineering fundamentals based on first principles understanding including critical thinking and systematic problem-solving skills as well as business acumen and learning agility are essential requirements to be successful in this position.
Working knowledge of packaging industry standards and regulations, including:
Packaging materials (flexible and rigid) & sterilization processes
Packaging Testing methods
Labeling Testing methods (PTS)
High volume regulated manufacturing
ISO-11607/ASTM D4169
ISO 13485/21 CFR Part 820
Experience with forming/sealing process and tooling for hard and soft blister packs, web materials made of thermoplastics and reinforced paper, shrink wraps, flow wraps, automatic case carton erection, labeling (materials, adhesives, inks/printing, etc.), UDI compliance and barcode printing/decoding are all strongly preferred.
Proficient in design & development of all levels of packaging with due consideration to safety, subsequent processing, environment & shipment logistics.
Strong technical judgement and leadership skills.
Product development considerations for tightly controlled, high-volume manufacturing process.
Disciplined in phase-gate product development and project planning.
Strong project management, prioritizing, and multi-tasking skills to work within tight deadlines.
Understanding of Measurement Systems Analysis (MSA).
Proficiency with statistical methods including DoE and data analysis using software such as Minitab.
Proficiency in solid CAD modeling (Creo, SolidWorks or equivalent) and design for manufacturability including injection molded and related systems and assemblies.
Proficiency with fixture design including basic machining considerations and developing test methods (fixture design and hands-on testing).
Proficiency with TOPS (or similar pallet configuration tool) is a plus.
Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies.
R&D functional planning, requirement generation and technical (DFSS/Design/Cross functional) reviews for all product development phases.
Proficiency with any of FEA and/or CFD modeling software is a plus.
Certified Packaging Professional through the Institute of Packaging Professionals is strongly preferred.
Ability to effectively and clearly communicate concepts, ideas, and knowledge to other individuals and teams.
Strong creative, analytical, and problem-solving skills required.
Good written and verbal communication skills.
Additional Job Description
Education
Bachelors/Masters/PhD in Mechanical Engineering or related Engineering discipline.
Seniority level
Executive
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Medical Equipment Manufacturing
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