Top 15 Biomedical engineer Jobs in New Brunswick, Nj

Medical Device V&V engineers
Katalyst Healthcares & Life Sciences —Avenel, NJ
- Contract
- 5 years
- English
- Analysis skills
Quick Apply
Senior Microfluidic & Mechanical Design Engineer (POC Diagnostic Platform)
Essenlix —Monmouth Junction, NJ
- Full-time
- 5 years
- Master's degree
- Welding
- Health insurance
- 401(k)
Quick Apply
Engineer I, Engineering GELP
WuXi Biologics —Cranbury, NJ
- Call employer
- Master's degree
- Doctor of Philosophy
- Travel
Principal Scientist, Cell Line Genome Engineering
Bristol-Myers Squibb —Princeton, NJ
- $135,800 - $164,563 a year
- Email
- Hybrid work
- Analysis skills
- Presentation skills
- Doctor of Philosophy
- Paid holidays
- Disability insurance
6d
Associate Principal Scientist, Upstream Development
Merck —Rahway, NJ
- $142,400 - $224,100 a year
- Full-time
- Master's degree
- Bachelor's degree
- Doctor of Philosophy
- Paid holidays
- Health insurance
Sr. Scientist, Lentivirus Upstream Processing
Legend Biotech US —Somerset, NJ
- $127,313 - $167,099 a year
- Full-time
- English
- 8 years
- Analysis skills
Principal Scientist, Upstream Development
Merck —Rahway, NJ
- $173,200 - $272,600 a year
- Full-time
- Master's degree
- 8 years
- Bachelor's degree
- Paid holidays
- Health insurance
Post Doc Associate
Rutgers University —Piscataway, NJ
- $63,968 a year
- Full-time
- Office
- Analysis skills
- University
- Paid holidays
- Dental insurance
Associate Principal Scientist, Upstream Process Development
Merck —Rahway, NJ
- $142,400 - $224,100 a year
- Full-time
- Master's degree
- Doctor of Philosophy
- Travel
- Paid holidays
- Health insurance
Principal Engineer, Lentivirus Downstream Process Development
Legend Biotech US —Somerset, NJ
- $146,410 - $192,164 a year
- Full-time
- Continuous improvement
- Doctor of Philosophy
- US work authorization
Quick Apply
Principal Scientist, Upstream Process Development
Merck —Rahway, NJ
- $173,200 - $272,600 a year
- Full-time
- 6 years
- Master's degree
- Doctor of Philosophy
- Paid holidays
- Health insurance
Senior Scientist, Viral Vector Process Development - Downstream
Rocket Pharmaceuticals —Cranbury, NJ
- $118,000 - $158,000 a year
- Full-time
- Microsoft PowerPoint
- Microsoft Word
- 6 years
- Paid holidays
- Health insurance
Coadjutant Non-Teaching
Rutgers University —Piscataway, NJ
- $20,000 a year
- Full-time
- Analysis skills
- University
- Doctor of Philosophy
- Paid holidays
- Dental insurance
Hourly Research Analyst
New Jersey Institute of Technology —Newark, NJ
- $15.92 an hour
- Part-time
- Residential
- University
- Bachelor's degree
Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs (Director Equivalent)
Merck —Rahway, NJ
- $156,900 - $247,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Product management
- Paid holidays
- Health insurance

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Medical Device V&V engineers

Katalyst Healthcares & Life Sciences -
Avenel, NJ

Quick Apply

Job Details

Contract

Qualifications

Optimizing workflow processes
Project reporting
Document compliance management
Quality control product testing
Medical device testing
ISO standards
5 years
Process design
English
In vitro studies
Collaboration with product development teams
Analysis skills
Quality risk management
Task prioritization
System validation
Compliance documentation
Quality compliance management
Systems engineering
Requirements management
Regulatory/legal compliance standards in production
Design controls
Biomedical regulatory compliance
Project risk assessment
In vivo studies
Senior level
Test validation method
Project leadership
Process management
Continuous process improvement (CPI)
Communication skills

Full Job Description

Summary:

We are seeking highly skilled and experienced System Engineers to join our team.
The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation.
This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle.

Roles & Responsibilities:

Design Controls: Lead efforts to develop and implement robust design control processes for new and existing products, ensuring compliance with FDA regulations (21 CFR 820), ISO 13485, and other relevant industry standards.
Traceability: Establish and maintain traceability throughout the design and development phases, ensuring that user needs, design inputs, and verification requirements are fully traced and documented.
User Needs to Design Validation: Work cross-functionally to trace user needs to design validation, ensuring that final products meet both the defined requirements and user expectations. This includes the development of comprehensive Design History Files (DHF) and validation documentation.
Design Verification & Validation (V&V): Collaborate with teams to ensure that all products undergo thorough design verification and design validation processes, providing evidence that the product meets the necessary specifications.
Cross-Functional Collaboration: Work closely with other engineering disciplines, such as hardware, software, and quality teams, to ensure a seamless integration of design controls and traceability throughout the product lifecycle.
Documentation and Reporting: Prepare and maintain detailed documentation for design control processes, ensuring all deliverables are compliant with internal and regulatory standards. Provide updates to leadership and stakeholders on project status, risks, and timelines.
Continuous Improvement: Identify areas for process improvements in design control and traceability methods, and implement changes that enhance the efficiency and effectiveness of product development.

Education & Experience:

Experience: 5-8 years of experience in system engineering within a regulated environment, preferably in medical devices or other highly regulated industries.
Design Controls: Strong experience in implementing and managing design controls processes, including traceability, user needs, and design verification/validation.
Traceability: Proven ability to ensure full traceability from user needs to design validation and manage product documentation accordingly.
Regulatory Knowledge: In-depth knowledge of FDA regulations (21 CFR 820), ISO 13485, and other applicable standards for medical devices.
Collaboration: Strong communication and interpersonal skills, with experience working effectively in cross-functional teams.
Strong verbal and written communication in English
Risk Management: Experience with risk management processes, including risk analysis, risk assessment, and mitigation strategies (e.g., ISO 14971).
V&V Experience: Familiarity with verification and validation techniques and methodologies for ensuring that product designs meet both functional and regulatory requirements.
Software and Tools: Experience with requirements management tools, traceability software, and common V&V tools.
Strong analytical and problem-solving skills
Ability to manage and prioritize multiple tasks in a fast-paced environment
Detail-oriented with a commitment to accuracy
Proactive and able to work independently or as part of a team V&V
We are seeking highly skilled and experienced V&V Engineers to join our team. The ideal candidate will have a strong background in Human Factors, Verification and Validation (V&V) activities, and tracing throughout the product development lifecycle.
The candidate must also have a solid understanding of FDA requirements for V&V reporting.
This individual will be responsible for ensuring that products meet regulatory and quality standards while maintaining alignment with user needs and design specifications.
Biocompatibility: Strong knowledge of biocompatibility testing and requirements, including testing standards such as ISO 10993.
Sterility: Experience with sterility requirements and testing, particularly in relation to medical devices.
Transport: Familiarity with transport testing and regulations for medical products, ensuring compliance with international shipping standards and guidelines.
Test Design: Experience in designing and conducting in vitro and in vivo testing, including test plan development, execution, and analysis of results.
Regulatory Knowledge: Familiarity with other global regulations, including ISO 13485, EU MDR, and others, is a plus.
Strong analytical and problem-solving skills
Ability to work independently and within a team environment
Detail-oriented with a focus on quality and regulatory compliance
Proactive, adaptable, and able to manage multiple tasks in a fast-paced environment

Quick Apply

Refine Your Search

biomedical engineer jobs in new brunswick, nj

Medical Device V&V engineers

Senior Microfluidic & Mechanical Design Engineer (POC Diagnostic Platform)

Engineer I, Engineering GELP

Principal Scientist, Cell Line Genome Engineering

Associate Principal Scientist, Upstream Development

Sr. Scientist, Lentivirus Upstream Processing

Principal Scientist, Upstream Development

Post Doc Associate

Associate Principal Scientist, Upstream Process Development

Principal Engineer, Lentivirus Downstream Process Development

Principal Scientist, Upstream Process Development

Senior Scientist, Viral Vector Process Development - Downstream

Coadjutant Non-Teaching

Hourly Research Analyst

Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs (Director Equivalent)

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