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Mentis Systems ยท 3 days ago
Product Development Engineer
Franklin Lakes, NJ
Contract
Hybrid
Mid Level
3+ years exp
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Responsibilities
Works under general direction to guide design and development of sterile medical device packaging.
Acts as Packaging subject matter expert on cross-functional teams to drive Packaging strategy and alignment to best practices.
Designs/engineers robust and manufacturable packaging using a combination of experience and engineering first principles.
Collaborates with Manufacturing and other associates to propose and implement packaging design/material/processes.
Independently determines and develops approaches to solutions and presents results to peers and business leadership.
Drives creative, logic, and risk-based approaches to resolve technical challenges under business constraints.
Develops, writes, and executes robust packaging test methods, protocols, data analysis, and reports.
Leads hands-on studies, design verification, validation, troubleshooting, and root-cause analysis for product packaging.
Performs data analysis, generates reports, and presents recommendations to peers and business leaders.
Supports material, packaging design, and process changes to existing products following design control processes.
Demonstrates a strong drive for results, accountability, and compliance with quality policies.
Provides advanced engineering skills and product packaging evaluation support to build business cases for new opportunities.
Qualification
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Required
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 Engineering Design (medical device sterile packaging design), 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.
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).
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.
Bachelors/Masters/PhD in Mechanical Engineering or related Engineering discipline.
Preferred
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.
Certified Packaging Professional through the Institute of Packaging Professionals is strongly preferred.
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.
Company
Mentis Systems
Mentis Systems specializes in CRM and ERP Integration, application and infrastructure outsourcing and other IT services.
1,001-5,000 employees
H1B Sponsorship
Mentis Systems 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
Trends of Total Sponsorships
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Shabu Khan
President & Chief Operating Officer
Company data provided by crunchbase
