R-D Engineer II

2 months ago

Minneapolis, United States LanceSoft Full time

Must Have:
1. Investigation and root cause analysis skills 2. Technical writing knowledge. Organization and Communication skills 3. Process validation knowledge close
Ability to work with department peers and middle-management within the marketing, engineering, and manufacturing functional groups.

JOB DESCRIPTION
Additional position detail from the manager below:
Can you please confirm your top 3 skills sets required?
R&D Experience in medical devices and the quality/regulatory processes around them. Experience in PVH products (Stents, Balloons, catheters, procedural support) would be beneficial. Ability to communicate and align cross functionally when working through problems.
Can you please confirm the 3 main responsibilities/day to day activities required for this role?
Coordinating with the quality and regulatory teams to develop test plans and change implementation plans. Interacting with suppliers and internal manufacturing sites to work through non-conformances and changes. Planning TM and TMVs.
What products (if any) will this role support?
Very likely our self-expanding Stent procedural support and/or Balloon product families.
What is your target years of experience?
2-5
When do you plan to start interviewing?
After the 4th of July holiday
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)?
We are currently Hybrid and typically work 3 days in the office but are staying flexible to everyone's needs
This role is within ***'s Peripheral Vascular Health organization's Released Product Management R&D team. The team covers a portfolio of devices that includes self-expanding stent, balloon expanding stents, drug and non-drug coated balloons, embolic protection, atherectomy, procedural support, chronic total occlusion, among others to treat the Peripheral Arterial Disease state. The team is responsible for sustaining released products and ensuring patient safety and quality requirements are continually met. This includes addressing changing regulatory requirements, working through internal and external manufacturing changes, conducting accelerated and real time aging, as well as the protocol/documentation associated with all the activities.

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: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

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