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Company

Original Job Post

Johnson & Johnson · 2 days ago

Product Design Consumables, Senior Manager

Irvine, CA

Full-time

Onsite

Senior Level

$135K/yr - $200K/yr

10+ years exp

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Health CareMedical Device

Comp. & Benefits

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Responsibilities

Recruit, train, motivate, review, and develop high-performance staff in the design and development of advanced ophthalmic surgical instruments, consumables, and accessories to achieve project milestones and business objectives

Collaborate with various stakeholders to define project requirements, specifications, and objectives

Coach the team in the use of design tools and techniques to create high-performing designs and engineering drawings

Architect systems, propose process improvements, and optimize for interoperability between consumables and capital equipment

Drive innovation efforts to identify and incorporate new technologies, materials, and design concepts

Identify opportunities for process improvements, propose design enhancements, and optimize product designs

Create, review, and approve change orders, technical reports, regulatory submissions, risk assessments, and promotional material

Develop and manage budgets, ensure compliance with policies and procedures, and manage laboratory/facility space and equipment safely

Qualification

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R&DProduct/Technology DevelopmentFunctional ManagementProject ManagementRegulated Industry ExperienceOphthalmology Industry ExperienceCADSolidworksModellingSimulationEngineering Change ControlProduct Lifecycle ManagementComplianceGeometric DimensioningTolerancingMetrologyFDA Design ControlsProcess DevelopmentRisk ManagementValidationStatistical AnalysisISO13485ISO14971Injection MoldingPlastic PartsPrecision Machining

Required

BS in Mechanical, Biomedical, Electrical, or a related engineering or science discipline is required.

10 years of experience including R&D and new product/technology development is required.

4 years of direct, functional management/supervision is required.

Experience with project management is required.

Regulated industry experience is required. Ophthalmology industry experience is preferred.

A record of successfully advancing innovation and bringing products to market is required.

Demonstrated sound scientific and engineering approach to problem solving and issue resolution, combined with a good understanding of relevant technologies at the theoretical level as well as their practical level, is required.

Expertise with CAD (Solidworks preferred but other packages are acceptable), modelling and simulation, engineering change control, product lifecycle management (ePDM), driving compliance to engineering drawing standards such as Geometric Dimensioning and Tolerancing per ASME Y14.5, and a strong understanding of metrology is required.

Mastery of the application of engineering fundamentals to achieve product design requirements is required.

Understanding of FDA design controls, process development and control, risk management, verification and validation, statistical analysis, and new product development under ISO13485 and 14971 standards is required.

Experience with high-volume injection molding of plastic parts and precision machining to tight tolerances is required.

This position may require up to 15% travel both domestically and internationally.