Principal Research

Job Title: Principal R&D Engineer

Type: Contract - 12 Months

Location: 2300 Berkshire Ln N Ste 5, Plymouth, MN

Day Shift

A Day in A Life

As a Principal R&D Engineer you will focus on delivering R&D to new therapies, from design to implementation while adhering to policies using specialized knowledge and skills. This role leads medium projects requires effective management and prioritization of multiple concurrent projects and tasks in an ambiguous environment. Responsibilities may include the following and other duties may be assigned:

§ Plan and manage medium sized projects, as asked by the project team and/or provide design technical guidance and consultation throughout cross-functional team projects to ensure effective planning, execution, and completion;

§ Develop customer and product specifications;

§ Prepare technical basis and justifications;

§ Apply statistical, modeling, and structured problem-solving techniques and interpret results to promote the design of medical devices, problem-solving, or basis for change implementation;

§ Develop, troubleshoot, qualify, and/or validate fixtures, equipment, and test methods utilized to evaluate product design and performance while considering clinical relevance;

§ Coach, train, review and/or delegate work to lower-level specialists;

§ Prepare engineering drawings with specifications and tolerances;

§ Create simulated use test plans/protocols, build prototypes, perform and/or oversee testing, analyze and document results, and create reports for design characterization, verification, and validation;

§ Process engineering change orders;

§ Assist in developing Failure Modes, Effects, and Criticality Analyses;

§ Present technical findings or project status to cross functional teams through meeting minutes, presentations, design reviews and other means of communication;

§ Perform job functions in accordance with applicable GMP and ISO standards;

§ Maintain required documentation per GDP procedures.

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

This role is in R&D, focused on development of new products. This role leads medium projects and requires effective management and prioritization of multiple concurrent projects and tasks in an ambiguous environment.

Plan and manage medium sized projects, as asked by the project team and/or provide design technical guidance and consultation throughout cross-functional team projects to ensure effective planning, execution, and completion

Create simulated use test plans/protocols, build prototypes, perform and/or oversee testing, analyze and document results, and create reports for design characterization, verification, and validation

Prepare technical basis and justifications

looking for a ‘generalist’ at this time, with exact program(s)/product to support to be determined. It is likely this person will support at least 2 different programs, wherever we need some extra help, and may change throughout the duration of the assignment. Looking for someone that can catch on quickly (note this is a principle level role), someone who may have to pivot quite quickly and be able to bring value to a program quickly. Looking for medical device industry experience.

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: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decision making. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Must Have – Minimum Qualifications

Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant medical device industry experience, or advanced degree with a minimum of 5 years of relevant medical device industry experience.

Nice to Have

§ Degree related to Mechanical or Biomedical Engineering;

§ Experience in medical device industry with Class III product and technologies;

§ Working knowledge of rapid prototyping and product design;

§ Experience with equipment and fixture development and qualification, test method development and validation (including clinically relevant methods);

§ Experience with design characterization, verification, and validation (including pre-clinical animal studies);

§ Ability to compile, organize, and communicate technical data using Excel, Word, Visio, and PowerPoint;

§ Experience using statistical techniques and software (e.g. DOE, Monte Carlo, ANOVA, Gage R&R, or Six Sigma tools and principles, and software – Minitab or JMP);

§ Experience creating engineering models and using common engineering software (e.g. CAD, MATLAB, PLM – Agile, Enovia or Windchill);

§ Experience working with Design for Manufacturing and Assembly or Design for Reliability and Manufacturability (or equivalent).

§ Project or Program Management experience or PMI PMP certification.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Can you please confirm your top 3 skills sets required?

Mechanical or Biomedical Engineering

Experience planning, leading and executing design verification and design validation

Experience in setting / defining a product specification

What products (if any) will this role support? Peripheral Vascular Health products used in the treatment of diseases of the veins or arteries.

What is your target years of experience? 7 years engineering total, with at least 4 years in medical device industry

Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

Benefits include:

-MEC/ACP Medical

-Voluntary Dental, Vision, Life, Supplemental Income

-401k (must meet requirements)

-sick leave as required by state/county