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Senior Design Product Engineer

Requisition Number: P11938

Region: US
State: Wisconsin
City: Hudson


We are seeking a Senior Design Project Engineer to work with
medical device products like injectables and infusion pumps, and other drug
delivery systems.  Will lead a cross functional team of technical
disciplines through the development process, from Concept through Design
Transfer in support of customer projects: 

  • Lead a cross functional team of technical disciplines through the DDP from Concept through Design Transfer:
    o   Learn and understand the Design Development Process and tools and the interdependencies of the different functional areas.
    o   Utilize critical thinking to facilitate discussions with the cross functional team
    o   Create, monitor, maintain and communicate the project scope, schedule, cost and risks, ensuring that the entire team understands their role in the project success.
    o   Direct and provide technical input to the project team and/or Program Manager (if applicable)
    o   Serve as the project lead for our customers while ensuring appropriate engineer-to-engineer communication is occurring between the project team members and their customer equivalents, as applicable.
    o   Review and approve design changes via the PDM and route for customer approvals.

  • On smaller projects, provide project management and technical direction to a small team. 
    o   Co-facilitate collaborative brainstorming (JumpStart®) sessions with an internal team, engaging with the customer in a variety of brainstorming activities.
    o   Manage multiple smaller projects simultaneously.
    o   Lead and/or co-facilitate a team through root cause analysis efforts.
    o   Be the single point of contact for the customer when working on capturing repeat, replacement or expanded scope business.  Work with the Business Development Team, Customer and Cost Estimating to generate new or updated proposals.

  • Provide strong project management direction to development teams:
    o   Create and/or provide direction for proposals and verify alignment between customer purchase order and the proposal
    o   Create, monitor and maintain project budget, scope, schedule and risk
    o   Facilitate project set-up and resource management by requesting resources from respective area managers, for specific scopes of work, and monitoring required team resources during project execution
    o   Work with the respective area manager(s) on team member training needs
    o   Work with appropriate financial personnel to generate financial and activity reports for communication and approval by the customer. 
    o   Ensure that the PMC production facilities are interacting with the development teams as required
    o   Manage the technical procurement needs of internal and external services/resources such as; contract personnel, purchased components, equipment and prototypes, etc.

  • Support product compliance by working with Quality to:
    o   Adhere to facility and corporate quality systems, SOP’s & WI’s
    o   Know and understand personal role in compliance to ISO 13485 w/ design controls, ISO14971 risk management, IEC 62366 & ITAR as required
    o   Ensure that design inputs and outputs are properly documented and controlled according to relevant procedures.
    o   Review and approve appropriate drawings, specifications and documents through the ECO or DCO process.
    o   Facilitate appropriate multi-disciplinary involvement in the creation of characterization or verification tests.
    o   Generate and control planning documents according to relevant work instructions

  • Facilitate communication between team members, customer and PMC production facilities
    o   Travel to Customer and PMC facilities as required to support business needs

  • Some programs may have vision requirements

  • Other duties as assigned

  • Safety/Environmental:
    o   Where applicable, individual is pre-planning safety into work activities to improve performance
    o   Proactively identifies safety concerns
    o   Complies with Environmental Management System program SOP’s/WI, Policy & Program elements and encourages responsible use of resources

  • Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction
    o   Completion of one of the following:
    -     Submission of a continuous improvement idea
    -     Active participation in a Phillips-Medisize sponsored committee or event
            Examples include a - Rapid Improvement Event, a 5S/Lean event, Safety
        Committee, Wellness Committee, Recycling Committee, Activity Committee, or
        other Phillips-Medisize sponsored community outreach project/event (United
        Way, Junior Achievement, etc.)

Qualifications - Education & Experience

  • Bachelor of Science in Engineering with minimum 3 years of product development leadership experience or 5-7 years Project Management experience in product development.

  • Demonstrated experience in managing budget, scope, schedule and risk.

Qualifications - Skills & Competencies

•Leadership skills including ability to lead and coordinate efforts across multiple disciplines while maintaining customer confidentiality
•Confident, educated decision making and prioritization skills
•Competent in ISO 13485 with design controls
•Familiar with ISO14971 risk management, IEC 62666
•Familiar with test protocol development, product verification activities and process validation
•Strong organizational, written, verbal and interpersonal communication skills
•Strong ability to manage project finances and schedule
•Experienced, respectful negotiation skills
•English, other languages a plus
•Strong critical thinking to guide complex design teams
•Fluent in Microsoft Office programs including Project, Excel, Word and Power Point

This facility operates
under International Traffic in Arms Regulations (ITAR), and therefore, any
person hired must demonstrate with verifiable documentation that he/she is
either: (i) a U.S. Citizen; (ii) an active Green Card Holder; or (iii) a
“Protected Person” as defined by 8 U.S.C. 1324(b)(a)(3).

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