Principal Mechanical Engineer

1 week ago

Franklin Lakes, United States MILLENNIUMSOFT Full time

Title: Principal Mechanical Engineer

Location: Franklin Lakes, NJ

Contract Term: 6+ Months

Shift/Hours: 1st Shift ( 8-9am to 4-5pm) / 40hrs

Client: Medical Device Company

Job Category: Engineering

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

This position will contribute to a global business within BD Medical, dedicated to delivering quality and innovative solutions in Hazardous Drug Safety (HDS) business. The business is committed to maintaining its accelerated growth through portfolio diversification, differentiated offerings and geographic / market expansions, while maintaining the profitability of the core product lines. We manage a healthy portfolio of programs ranging from incremental innovation to disruptive & breakthrough opportunities enabling medication delivery solutions. Our engineers and scientists have passion for bringing innovative technical solutions to meet serious unmet clinical needs, have strong records of professional achievement, and have the desire for continuous development and growth. We strive to provide individuals with opportunities to develop skills, gain and share knowledge, understand and deliver what our customers need and build a rewarding and fulfilling career.
We are recruiting for a driven technical professional having a passion for problem solving and a proven track record of successfully developing medical products. Reporting to the Senior Staff Engineer / Product Lead Designer within the R&D function, the successful candidate has a unique opportunity to join a high-caliber global R&D team responsible for test method development, verification and validation in a growing business within BD Medication Delivery Solutions (MDS) business unit.

The incumbent will join the Verification & Validation Test Engineering team as a Contract Engineer, providing technical support to a cross-functional team. The successful candidate will be responsible for supporting product verification activities and will assist test method development activities, measurement system development & analyses, test fixture design and equipment hardware/software validation of measurement system equipment. The ideal candidate will also participate in executing technical and cross-functional project work which may include all phases of product development, including design and development planning, requirements definition, product development, root cause analysis, test method development, and design verification/validation. Responsibilities include but not limited to the following.

• Define, plan and lead activities, including, test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification.
• Participate in the planning and execution of technical project work. This will involve the application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions.
• Critically evaluate and analyze system performance and reliability and ensure the design space is adequately pressure-tested to satisfy user, regulatory and business requirements. Understand system and subsystem design sensitivity and identify and address early any potential design integration and transfer risks.
•Learn and eventually implement DFSS rigor throughout the design selection and development process, leveraging and deploying empirical, statistical and analytical tools which will improve design decisions and reduce design iteration cycle times.
•Learn and eventually ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, usability, reliability and safety.
• Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
• Actively build on personal skills, expertise, and competencies. Ensure that technical lessons are reviewed, learned, and disseminated.
• Ensure compliance with BD quality policies, procedures, and practices.
• Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures

Minimum Qualifications:
o Bachelor’s degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering with mechanical emphasis or related field.
o 0-3 years of post-baccalaureate professional experience supporting product development projects
o Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions
o Experience in modeling, simulations using Finite Element Methods [Eg: ABAQUS] and sensitivity analyses
o Experience with design best practices, including advanced tolerance design, and design for reliability.
o Working with regulatory standards
o Ability to multi-task, project management on multiple cross-functional projects

Desired Qualifications:
o Graduate degree (MS) in Mechanical Engineering, Biomedical Engineering, or related field
o 0-2+ years of post-educational experience in Medical Device Design
o Fundamental knowledge of Design for Six Sigma, Design for Manufacturability
o Knowledge of injection molded plastics and design of high-volume disposables
o Development of medical disposable devices
o Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies highly desired
o Knowledge in common risk management techniques highly desired
o Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired

Competencies:
o Excellent written & verbal communication skills
o Ability to learn and adapt quickly to multiple and competing requests.
o Must be comfortable making practical assumptions with engineering justifications, where needed.
o Ability to work independently.
o Ability to work under pressure and time constraints.
o Effective interpersonal and collaborative skills.
o Deals with ambiguity, making practical assumptions with engineering justification where needed

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