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Product Development at Indotronix International Corporation

Product Development

Indotronix International Corporation Franklin Lakes, NJ (On Site) Contractor
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Candidate is expected to work 3 days a week at location and 2 days remote and this may change based on policies.

The R&D Verification & Validation team within Medical - Medication Delivery Solutions (MDS) is seeking a highly talented and passionate individual to help the team identify innovative solutions to address current and future health care needs in the medication delivery markets.

The incumbent will join as a Contract Engineer, requiring moderate oversight and providing technical leadership and support to a cross-functional team. The successful candidate will be responsible for: supporting product verification activities; contributing to – and possibly leading – test method development activities; measurement system development, analysis and qualification; test fixture design; supporting existing CAPAs; creation and execution of design verification strategies required for sustaining existing and commercialization of various types of new medical device products used in drug delivery.
The ideal candidate will plan and 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; design verification/validation and support design transfer. Additionally, the candidate will be expected to participate in the development of new technologies for testing products that will help meet current and future clinical unmet needs.

Responsibilities :
Specific responsibilities will include the following as well as other duties as assigned:
• Provide technical direction and oversight of V&V test method development activities. 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.
• Collaborate with Systems and Engineering teams to understand and derive specifications for a broad portfolio of MDS products.
• Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
• Resolve technical problems. Identify or create solutions for technical problems using systematic problem-solving and statistical methodologies.
• Support project plan development and contribute to the development of the Design Verification and Validation strategy.
• Conduct and encourage frequent formal and informal communication with the team to ensure full engagement and efficient operation.
• Expected to mentor associates in related technical roles. Provide technical direction and frequent feedback.
• Developing personal skills, expertise, and competencies. Ensure that technical lessons are reviewed, learned, and disseminated.
• Ensure compliance with quality policies, procedures, and practices.
• Ensure compliance with all local, state, federal, and safety regulations, policies, and procedures

EDUCATION & EXPERIENCE :
Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or related technical field;
3+ years experience.

KNOWLEDGE, SKILLS AND ABILITIES :
• Strong technical judgment and technical leadership skills.
• Demonstrated capability of leading R&D projects.
• Experience in guiding team/individuals to develop technical solutions to complex problems.
• Sound knowledge of engineering first principles.
• Strong project management, prioritizing and multi-tasking skills to work within tight deadlines. Proficient in Microsoft Project.
• Proficient in solid modeling (Pro/E, SolidWorks or equivalent).
• Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
• Experience in directing associates and leading small cross-functional groups is required.
• Proficiency with fixture design including basic machining considerations and developing test methods.
• Knowledge of Measurement Systems Analysis (MSA).
• Basic knowledge and Ability to apply Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies.
• Strong creative, analytical and problem solving skills required.
• Good written & verbal communication skills.

  • Responsibilities:
    Specific responsibilities will include the following as well as other duties as assigned:
    • Provide technical direction and oversight of V&V test method development activities. 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.
    • Collaborate with Systems and Engineering teams to understand and derive specifications for a broad portfolio of MDS products.
    • Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
    • Resolve technical problems. Identify or create solutions for technical problems using systematic problem-solving and statistical methodologies.
    • Support project plan development and contribute to the development of the Design Verification and Validation strategy.
    • Conduct and encourage frequent formal and informal communication with the team to ensure full engagement and efficient operation.
    • Expected to mentor associates in related technical roles. Provide technical direction and frequent feedback.
    • Developing personal skills, expertise, and competencies. Ensure that technical lessons are reviewed, learned, and disseminated.
    • Ensure compliance with quality policies, procedures, and practices.
    • Ensure compliance with all local, state, federal, and safety regulations, policies, and procedures

Recommended Skills

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