Sr Reliability Engineer

ATR ID:

ATR224765

Job Title:

Sr Reliability Engineer

Job Level:

Electrical/Hardware Engineers

Duration:

12 months

Location:

Mounds View

MN 55112

Education:

Bachelors Degree; Bachelors Degree Electical Engineering battery development

Email:

Forrest, Preston

Phone:

980-270-6225 Pay rate: $50.00

• $70.

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.

Job Description:

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

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 .

Requirement:

Must Have a Biomedical Engineer Bachelors Degree; Bachelors Degree Electical Engineering battery development Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), PMCF Plans and Reports, PMS Reports, SSCPs, and Benefit-Risk Analyses in alignment with

EU MDR 2017/745, MEDDEV

guidelines, ISO 13485, MDCG guidance, and US FDA requirements With a strong foundation in systematic literature review methodologies, I critically appraise clinical and scientific evidence to support GSPRs, state of the art, risk assessments, and the safety and performance of medical devices Known for precision, regulatory insight, and scientific clarity, I deliver compliant, audit-ready documentation that strengthens product submissions and supports clients' regulatory success across diverse device categories Senior Lead, Nov 2017

• Mar 2022 HCL Technologies Pvt Ltd
• Hyderabad, Telangana
• Authored and reviewed key clinical documents:

CEP, CER, PMCF

Plan/Report, PMS Report, SSCP for clients including Abbott Vascular, Baxter, and Boston Scientific

• Proficient in medical device regulations: EU MDR (2017/745), MEDDEV 2.7/1 rev 4, MEDDEV 2.12/2 rev 2, ISO 13485, ISO 14971, 21 CFR part 820, MDCG guidelines, US FDA, and global standards
• Conducted systematic literature reviews for state-of-the-art, risk assessment, and device safety/performance evaluations
• Collaborated with cross-functional teams (PMS, QA, R D, RA) throughout the CER development process
• Responded to Notified Body queries and evaluated the necessity for PMCF activities
• Led CER gap assessments and remediation in alignment with MEDDEV and MDR requirements
• Mentored team members, trained staff on regulatory documentation, and ensured stakeholder alignment on project goals Medical Writer, Jul 2015
• Sep 2017 Jeevan Scientific Tech Ltd
• Hyderabad, Telangana Writer/reviewer for articles, posters, slide decks, newsletters, book chapters, scientific content (CME, Phase IV studies, case reports, posters) across key therapeutic areas: diabetes, oncology, cardiology, dental, and musculoskeletal disorders

Clients:

Dr Reddy's, Sanofi, AstraZeneca, Colgate, Novo Nordisk, Pfizer Clinical Trial Assistant (Consultant), Apr 2014

• Dec 2014 Novartis Healthcare Pvt Ltd
• Hyderabad, Telangana Drafted clinical overviews (ICH-CTD 2.

5) to update PK/PD and interaction data in core data sheets (CDS) for established medicines Provided CDS training to new employees. Med device industry experience Nice To Have Academic Collaboration Adaptability Can you please confirm your top 3 skills sets required? Electrical Engineering, Biomedical Engineering, Risk Management Can you please confirm the 3 main responsibilities/day to day activities required for this role? Project Support, Post Market Deliverables, Manufacturing Support What products (if any) will this role support? Supporting CRM (Cardiac Rhythm Management) specific to pacemakers and leads relating to Defibrillation Solutions and Cardiac Pacing Therapies What is your target years of experience? For this role around 4-6 years would be a tight range but would be slightly flexible either way, looking for the right fit.

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. How to

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