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    Sr R/D Engineer - Minneapolis, United States - LanceSoft

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    Description

    Nice to Have:
    A demonstrated capacity for solving problems through creative designs
    BS or MS in Mechanical Engineering or equivalent with 7+ years progressive mechanical design experience in a regulated medical industry
    Knowledge and experience using DFMECA FMEA, DOE
    Knowledge and experience with statistical analysis (Minitab, ANOVA)
    Knowledge of FDA and ISO 13485:2003 to manage medical device materials, related processes, and GMP (Good Manufacturing Practices)
    Proven communication skills and ability to lead within a multi-functional team environment
    Utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why's, Ishikawa (Fishbone)


    JOB DESCRIPTION
    Additional position detail from the manager below and attached:


    Can you please confirm your top 3 skills sets required? Understanding of CAD/drawings/models, experience using DFMECA/PFMECA/DOEs, experience using problem solving techniques (A3s, DMAIC, 5 Whys, Fishbone, etc.).

    We would also prefer someone with medical device experience and strong collaboration skills as this role will be partnering with our Grand Rapids site.

    Can you please confirm the 3 main responsibilities/day to day activities required for this role? This role will support the integration activities for the newly acquired Grand Rapids, MI site (role will sit in Brooklyn Park).

    They have a lot of new equipment coming in, so we will need someone to collaborate on and approve validation work to ensure all design needs are met.

    There will also likely be component specification remediation work; there are instances where manufacturing can't use some components because the drawing specifications aren't manufacturable, so we will need someone to ensure changes don't impact the final product design.

    This would also include updating CAD models and drawings where applicable.

    This person would also be the day to day R&D support engineer, so could get pulled into issues that arise in production/quality.

    What products (if any) will this role support? Cardiopulmonary Cannula portfolio
    What is your target years of experience? 7+
    When do you plan to start interviewing? ASAP
    Will you be looking to hire and start ASAP or will the start date be delayed? ASAP
    Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Fully onsite at Brooklyn Park

    Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products.


    SPECIALIST CAREER STREAM:
    Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals.

    The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).


    DIFFERENTIATING FACTORS Autonomy:
    Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.


    Organizational Impact:
    May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.


    Innovation and Complexity:
    Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.


    Communication and Influence:
    Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.


    Leadership and Talent Management:
    May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .


    Required Knowledge and Experience:
    Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.

    Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



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