Find & Apply For Validation Engineer Jobs in Mounds View, Minnesota

ATR ID:

ATR226697

Job Title:

Sr Reliability Engineer - Exempt

Job Level:

Manufacturing/Process/Quality Engineers

Duration:

12 months

Location:

Mounds View

MN 55112

Education:

Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

Email:

Nguyen, Jonathan

Phone:

408-899-3965

Pay rate:

$50.00 - $65.00 (Hourly)

Benefits:

• Benefits
• Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws. Compensation
• Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select. Work Authorization

ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization. ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees. Responsibilities may include the following and other duties may be assigned Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability Completes risk analysis studies of new design and processes Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes Ensures that corrective measures meet acceptable reliability standards Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives May develop mathematical models to identify units, batches or processes posing excessive failure risks As necessary, proposes changes in design or formulation to improve system and/or process reliability May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data

TECHNICAL SPECIALIST CAREER STREAM

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies Formulates, 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 R D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.

Requirement:

TECHNICAL SKILLS

Must Have

1 Previous experience on Quality Systems & CAPA, Change Control and Validations 2 Knowledgeable on Medical Device Regulatory Requirements 3 Previous experience with Quality & Regulatory Audit activities

a Reliability Engineer 1. Can you please confirm your top 3 skills sets required? Manufacturing support, Project and program support, CAPA and cross functional collaboration 1. Can you please confirm the 3 main responsibilities/day to day activities required for this role? Supporting multiple sites, CAPA Support, understanding quality/post market quality deliverables 1. What products (if any) will this role support? CRM products (Pacemakers and leads)

2. What is your target years of experience? 5-15 years

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 in-depth 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 decision-making

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 a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience. How to

Apply:

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