Job Description

The HW Engineering Manager will be a hands-on manager working closely with his/her direct reports throughout every phase of the product life-cycle to ensure the products meet customer expectations and Olympus quality standards. The manager will oversee the analysis, characterization, and overall development of embedded hardware design for medical devices. The manger will be responsible for embedded HW development process and will participate in DFMEA analysis, system design reviews, project reviews, etc. They will work collaboratively with other departments in the planning and execution of projects. The manager is expected to recruit, mentor, and groom a world class team of embedded HW engineers and making sure the team has proper tools to perform their job.

Job Duties

• Provides significant contributions to sustaining products, product development projects and/or technology development efforts.

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  Work with internal and external design partners to advance design efforts.

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  Provide design guidance relating to hardware and product design.

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  Participate in creation and revision of requirements ensuring traceability to User Needs and test cases.

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  Support the requirements development and management process, incorporating risk management elements as required.

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  Creates development procedures in adherence to medical device regulations.

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  Support the creation of design control elements to comply with medical device regulations.

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  Implement product design with the intention of optimizing design for manufacturability and testability.

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  Develop verification and validation testing strategies and ensures products meet and/or exceed established specifications.

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  Provides regular updates to engineering and marketing leadership on product status and advancement.

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  Works with Marketing and engineering teams to create marketing claims.

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  Stay informed about new tools, regulations, standards, and best practices of the industry.

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  Supports leadership as required.

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  All additional duties as directed.

Job Requirements

REQUIRED QUALIFICATIONS:

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  Bachelor’s degree in Electrical Engineering.

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  Minimum of 12 years professional experience and minimum of 5 years people management.

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  Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.

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  Capable of creation of design control deliverables and input to the Design History file either independently or under the guidance of the project technical lead.

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  Knowledge of IEC60601-1.

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  Knowledge of software lifecycle management in compliance to EN62304 Ability to effectively work within a requirements management system, such as Doors, JAMA, etc and perform hardware risk analyses and hardware DFMEAs.

PREFERRED QUALIFICATIONS:

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  Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc..

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  Working knowledge of schematic and PCB layout tools (Altium, Mentor, etc).

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  Ability to troubleshoot circuit and system level issues. Must be able to develop project schedules.

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  Must have capable of developing test strategies for complex systems. Experience problem solving system design issues (e.g., electromagnetic compatibility). Must be able to solve complicated technical challenges and use good judgement in making timely decisions.

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  Must be able to collaborate effectively with others, works well within cross-functional teams and across multiple sites, as applicable.

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  Must be capable to effectively executing on multiple work streams in parallel.

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  Must be able to communicate effectively, both verbally and in writing. Comfortable presenting information to team members and stakeholders.

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  Must be able to work in a professional open-space environment without distracting others.

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  Must have a positive attitude and capable of accomplishing efforts in a timely manner and with high quality.

** The anticipated compensation range for this position is $123,000 to $173,000 USD annually and the compensation offered will depend on the candidate’s qualifications.

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