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field_job_occupational_field_parents_all

job_organization_name

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<h3>Job Description</h3>
Job Description
You have a Ph.D. in an Engineering discipline and 5+ years of Bioengineering/Biomechanics experience post-doctoral work. You want to use your training, education, and experience in a new and meaningful way.
Robson Forensic, a longstanding national forensic expert firm with an excellent reputation in the legal and scientific community, is looking for a Biomedical/Biomechanical Engineering Expert like you to provide investigation, analysis, reports, and testimony where technical and scientific answers are needed to help resolve civil and criminal litigation and insurance claims. 

 
Description:
 
Our Biomechanical Engineering Experts apply scientific and engineering principles of bioengineering and biomechanics to investigate incidents involving claimed injuries/fatalities due to an event. 
The areas of investigation may include impact and injury biomechanics/orthopedic biomechanics applied to events such as vehicle collisions, sports and recreation, occupation, assaults, falls etc. Additionally, we also apply our knowledge, experience, education, and training to evaluate medical device failures. 

 
Location:
 
PA
 
Requirements:
 
<ul>
<li>You have a Ph.D. in an engineering discipline. </li>
<li>You have a B.S. in Engineering from an ABET accredited University.</li>
<li>You have 5+ years of bioengineering/biomechanics experience post-doctoral work. </li>
<li>Your Traumatic Brain Injury (TBI) experience is a plus.</li>
<li>You can work both independently and as part of a comprehensive team.</li>
<li>You have excellent technical, analytical, writing, and communication skills.</li>
<li>You are willing to travel about 20% on average.</li>
</ul>
 
ABOUT US:
 
Robson Forensic is a national leader in expert witness consulting, providing technical expertise across many fields within engineering, architecture, science, and a broad range of specialty disciplines.
Employees at Robson Forensic work alongside highly respected experts from both industry and academia. Our forensic experts are engaged in meaningful casework that is consequential to industry and society. Robson Forensic provides a unique working dynamic that blends collaboration and autonomy.
 
HOW TO APPLY:
 
If you are looking for a challenging and rewarding position, and you meet our minimum requirements, please apply, and attach your resume and cover letter (outlining your professional background and expertise). We thank all applicants for their interest; however, only those under consideration will be contacted.
We are an Equal Opportunity Employer.

Biomechanical Engineer

<h3>Job Description</h3>
Job Description
Job Title: Senior Principal Quality Engineering Leader – Medical Device R&amp;D
Duration: 12 Months
Location: Bellevue WA 98005
Role &amp; Responsibilities:
Provide Quality Engineering leadership for software and hardware product development teams.
Responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.
Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.
Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation.
Responsible for quality oversight and approval of product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, and the software BOM, lead implementation of best practices for software quality processes.
Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.
Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects.
Guide triage and remediation efforts.
Secondary/Backup Duties and Responsibilities:
• Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
• Own the resolution and timely closure of CAPAs as they relate to the design control process.
• Provide Quality Engineering support for released products, interfacing with customer support representatives and account executives as necessary.
• Support other areas of the Quality System and perform other tasks as defined by Management.
Required Qualifications, Education and Experience:
• Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
• Experience in the design, development, verification, validation, and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non- embedded software.
Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
• Exceptional verbal and written communication skills and presentation skills.
• Exceptional attention to detail with the proven ability to wear many hats.
• Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
• Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
• Creative problem solver.
• Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.
Additional Qualifications:
• Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.
• Experience with artificial intelligence, working within an AAMI TIR45 framework, and SaMD is preferred.
• Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is preferred.
• 8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development.
• B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs. Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities 
<h3>Company Description</h3>
Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities

Sr. Principal Engineer

<h3>Job Description</h3>
General Summary
John Moriarty &amp; Associates of Virginia (JMAV) is seeking a full-time Field Engineer in the Washington DC Metro area.
 
Field Engineers with Moriarty are responsible for assisting the Superintendent with direction and control of field forces (both Moriarty employees and subcontractors) to ensure that the project is built according to plan, specification, schedule, and quality.
 
The Field Engineer should be located within daily driving distance of the Washington DC Metro area.
 
Roles &amp; Responsibilities:
The Field Engineer must have the basic ability to read and interpret plans &amp; drawings, understand the importance of jobsite safety, and be able to effectively present information. Some responsibilities include:
 
<ul>
<li>Assist field personnel in their site-specific responsibilities.</li>
<li>Assist field personnel in quality control inspections and documentation.</li>
<li>Ability to perform construction material takeoffs and make estimates for future needs.</li>
<li>Understand company / project safety plan.</li>
<li>Assist with administration of subcontractor safety training and compliance.</li>
<li>Asist with coordinating subcontractor deliverables for project execution.</li>
<li>Assist in processing submittals.</li>
</ul>
 
Education:
<ul>
<li>4-year degree preferred, in Building Construction or relevant subject.</li>
</ul>
 
Work Experience: 
<ul>
<li>0-2 years of project management experience, in Construction is preferred. </li>
</ul>
 
Knowledge, Skills, and Abilities:
<ul>
<li>Excellent communication skills, both verbal and written</li>
<li>Adaptable team players, with strong client service skills</li>
<li>Basic understanding of construction drawings and specifications</li>
<li>Basic understanding area schedules</li>
<li>Basic knowledge of Microsoft Excel and Smartsheet scheduling</li>
<li>OSHA 10 certification</li>
<li>First Aid / CPR certification</li>
</ul>
 
Physical Requirements:
<ul>
<li>This position will require moderate physical activity</li>
<li>Driving between sites, climbing stairs and ladders, walking on rough terrain, standing for extended periods of time </li>
</ul>
 
Work Environment:
<ul>
<li>Work onsite, outdoors, in all weather conditions. The noise in these work environments is usually moderate to very loud. The employee will be regularly exposed to outside weather conditions.</li>
</ul>
 
The Company:
John Moriarty &amp; Associates of Virginia (JMAV) is a privately held general contractor that specializes in large scale, urban, ground-up projects such as mixed-use, multi-family, hotels, senior living, student housing and bio-medical and is one of the faster growing contactors in the DC-Metro area. Exceptional for the industry, 100% of our projects are negotiated with over 85% being with repeat clients. 
 
Our approach is characterized by transparency, collaboration, attention to detail and hands-on leadership. Our projects are set up for success by our strong emphasis on pre-construction services and planning, proper staffing and hiring best-in-class subcontractors. Our growth has been a result of outstanding execution in every phase of project delivery and an unparalleled employee retention of the best people in the industry.
 
Our parent company, John Moriarty &amp; Associates (JMA), was founded in 1985 in Winchester, MA and is one of the most respected general contracting firms in the industry. Learn more about us at <a href="http://www.jma-va.com" target="_blank">www.jma-va.com</a> and <a href="http://www.jm-a.com" target="_blank">www.jm-a.com</a>.
 
 
John Moriarty &amp; Associates of Virginia participates in E-Verify for all hired employees. E-Verify is a web-based system that allows enrolled employers to confirm the eligibility of their employees to work in the United States by electronically matching information provided by employees on the Form I-9 against records available to the Social Security Administration and the Department of Homeland Security. More information can be found at <a href="http://www.e-verify.gov" target="_blank">www.e-verify.gov</a>.

Field Engineer (Dec 2025/May 2026 Grads)

<h3>Job Description</h3>
General Summary
John Moriarty &amp; Associates of Virginia (JMAV) is seeking a full-time Field Engineer in the Charlottesville, VA area.
 
Field Engineers with Moriarty are responsible for assisting the Superintendent with direction and control of field forces (both Moriarty employees and subcontractors) to ensure that the project is built according to plan, specification, schedule, and quality.
 
The Field Engineer should be located within daily driving distance of the Charlottesville, VA area.
 
Roles &amp; Responsibilities:
The Field Engineer must have the basic ability to read and interpret plans &amp; drawings, understand the importance of jobsite safety, and be able to effectively present information. Some responsibilities include:
 
<ul>
<li>Assist field personnel in their site-specific responsibilities.</li>
<li>Assist field personnel in quality control inspections and documentation.</li>
<li>Ability to perform construction material takeoffs and make estimates for future needs.</li>
<li>Understand company / project safety plan.</li>
<li>Assist with administration of subcontractor safety training and compliance.</li>
<li>Asist with coordinating subcontractor deliverables for project execution.</li>
<li>Assist in processing submittals.</li>
</ul>
 
Education:
<ul>
<li>4-year degree preferred, in Building Construction or relevant subject.</li>
</ul>
 
Work Experience: 
<ul>
<li>0-2 years of project management experience, in Construction is preferred.</li>
</ul>
 
Knowledge, Skills, and Abilities:
<ul>
<li>Excellent communication skills, both verbal and written</li>
<li>Adaptable team players, with strong client service skills</li>
<li>Basic understanding of construction drawings and specifications</li>
<li>Basic understanding area schedules</li>
<li>Basic knowledge of Microsoft Excel and Smartsheet scheduling</li>
<li>OSHA 10 certification</li>
<li>First Aid / CPR certification</li>
</ul>
 
Physical Requirements:
<ul>
<li>This position will require moderate physical activity</li>
<li>Driving between sites, climbing stairs and ladders, walking on rough terrain, standing for extended periods of time</li>
</ul>
 
Work Environment:
<ul>
<li>Work onsite, outdoors, in all weather conditions. The noise in these work environments is usually moderate to very loud. The employee will be regularly exposed to outside weather conditions.</li>
</ul>
 
The Company:
John Moriarty &amp; Associates of Virginia (JMAV) is a privately held general contractor that specializes in large scale, urban, ground-up projects such as mixed-use, multi-family, hotels, senior living, student housing and bio-medical and is one of the faster growing contactors in the DC-Metro area. Exceptional for the industry, 100% of our projects are negotiated with over 85% being with repeat clients.
 
Our approach is characterized by transparency, collaboration, attention to detail and hands-on leadership. Our projects are set up for success by our strong emphasis on pre-construction services and planning, proper staffing and hiring best-in-class subcontractors. Our growth has been a result of outstanding execution in every phase of project delivery and an unparalleled employee retention of the best people in the industry.
 
Our parent company, John Moriarty &amp; Associates (JMA), was founded in 1985 in Winchester, MA and is one of the most respected general contracting firms in the industry. Learn more about us at <a href="http://www.jma-va.com" target="_blank">www.jma-va.com</a> and <a href="http://www.jm-a.com" target="_blank">www.jm-a.com</a>.
 
 
John Moriarty &amp; Associates of Virginia participates in E-Verify for all hired employees. E-Verify is a web-based system that allows enrolled employers to confirm the eligibility of their employees to work in the United States by electronically matching information provided by employees on the Form I-9 against records available to the Social Security Administration and the Department of Homeland Security. More information can be found at <a href="http://www.e-verify.gov" target="_blank">www.e-verify.gov</a>.

<h3>Job Description</h3>
Job DescriptionDescription:
At Esaote North America, we believe that technology is not truly state-of-the-art unless it serves real world needs. We understand the demands of today's clinical environments, and we continue to develop MRI and ultrasound systems that are user-friendly and patient-friendly, ergonomic and affordable. 
 
Esaote North America is seeking an experienced MRI Field Service Engineer to join our service team. This remote, field-based role provides technical support for Esaote MRI systems, including installation, preventive and corrective maintenance, troubleshooting, upgrades, and customer support. The ideal candidate will be based in the Atlanta area to support customers throughout the region, with potential national travel as needed.
What You’ll Do:
<ul>
<li>Perform on-site service, diagnostics, and repairs on Esaote MRI systems. </li>
<li>Install and commission MRI systems, ensuring quality and regulatory compliance. </li>
<li>Conduct preventive maintenance and safety checks. </li>
<li>Provide system operation training and support to customers. </li>
<li>Document service activities and communicate feedback to the service team. </li>
<li>Collaborate with engineering, technical support, and service leadership. </li>
</ul>
What We’re Looking For:
<ul>
<li>Associate or bachelor’s degree in Biomedical or Electrical Engineering (or related field); military-equivalent training considered. </li>
<li>3+ years of hands-on field service experience with diagnostic imaging equipment; MRI experience required (Esaote or open MRI strongly preferred). </li>
<li>Strong technical skills in MRI subsystems, networking/DICOM, and use of diagnostic equipment. </li>
<li>Ability to travel extensively (up to 75%) with overnight stays. </li>
<li>Valid driver’s license with clean record. </li>
<li>Must meet hospital credentialing requirements. </li>
</ul>
Preferred Certifications:
<ul>
<li>OEM MRI System Certification (Esaote or other) </li>
<li>AAMI CBET or CRES </li>
<li>OSHA 10/30 Safety Certification </li>
</ul>
Why Join Esaote: As part of a global leader in medical imaging, you’ll play a key role in supporting innovative MRI technology that makes a difference in healthcare. We offer a competitive compensation and benefits package, a collaborative culture, opportunities for professional growth, and the chance to represent a company known for quality and innovation. 
 
Esaote North America is an Equal Opportunity Employer and is committed to diversity, inclusion, and compliance with the ADA.
Requirements:

Field Service Engineer - MRI

<h3>Job Description</h3>
Job DescriptionDescription:
RIVANNA is seeking a Product Development Engineer to join our dynamic engineering team. You will work with a talented team of professionals as we strive to achieve our mission to develop and commercialize world-first imaging-based medical technologies that elevate global standards of care. As a Product Development Engineer, you will contribute to activities across the product lifecycle, from prototype development to clinical support. This hands-on multidisciplinary role involves close collaboration with the mechanical, manufacturing, and electrical engineering team on a wide range of product development tasks and projects. This job will be on-site in Charlottesville, VA; applicants must be local or willing to relocate to Charlottesville for this position.
 
Responsibilities
<ul>
<li>Product Development: Support the development and improvement of medical devices and manufacturing processes </li>
<li>Testing: Design and execute test methods to verify subsystem and system performance, analyze data, and document results in test reports</li>
<li>Prototyping &amp; Fabrication: Operate and maintain 3D printers and machine shop equipment (e.g., mill, lathe, drill press) to support prototype and fixture fabrication</li>
<li>Manufacturing: Assist with the assembly of electromechanical systems for engineering builds, internal testing, and clinical evaluation</li>
<li>Documentation: Create and update design control and design transfer documentation including work instructions, BOMs, test plans, and test reports</li>
<li>Field Service: Provide technical support for systems in the field, including remote troubleshooting and occasional travel to clinical sites</li>
<li>Cross-functional Collaboration: Work closely with engineering, production, and clinical teams to support product development and sustaining efforts</li>
</ul>
Requirements:
<ul>
<li>Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline</li>
<li>1-3 years of relevant industry experience in product development or R&amp;D (medical device experience preferred)</li>
<li>Hands-on experience with hand tools, power tools, 3D printing, soldering, and test equipment</li>
<li>Experience with SolidWorks or similar CAD software preferred</li>
<li>Exposure to medical device regulations and quality systems including ISO 13485, FDA design controls (21 CFR), and risk management processes (ISO 14971).</li>
<li>Strong organizational, communication, and technical writing skills</li>
<li>Ability to work independently and on cross-functional teams in a fast-paced environment</li>
<li>Willingness to travel occasionally (=10%) for field service support</li>
<li>Applicants must be authorized to work in the United States without the need for current or future sponsorship. RIVANNA is unable to provide employment sponsorship for this position.</li>
</ul>
About Rivanna Medical, Inc.: RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world's first spinal navigation device designed to improve the safety, speed, and efficiency of spinal needle guidance procedures. RIVANNA's revolutionary platforms feature BoneEnhance® Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.
 
Employee Benefits at Rivanna Medical: Rivanna Medical offers a comprehensive benefits package, which includes health insurance, vision and dental coverage, group life insurance, long-term disability insurance, paid time off, a 401(k) plan with company match, and more. We are continually seeking to enhance our team with individuals who bring unique perspectives and experiences. This diversity of thought and perspective drives innovation and strengthens our commitment to creating an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.
 
Equal Employment Opportunity Statement: Rivanna Medical is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws.All employees must be able to lift at least 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of their positions.

Product Development Engineer

<h3>Job Description</h3>
Job Description
Heinze Consultants LLC (founded 2016) is a high-technology consultancy solving complex electrical and systems-engineering problems for mission-critical aerospace, defense, and biomedical programs. Our team brings 40+ years of leadership across RF/spread spectrum, embedded systems, and applied AI/ML. We execute with rigor—on time, on budget, to spec.
What You’ll Do
<ul>
<li>
Lead architecture, design, and verification of RF/embedded subsystems and mixed-signal electronics for flight- or mission-critical use.
</li>
<li>
Build requirements and traceability (IBM DOORS), develop ICDs, interface specs, and verification plans.
</li>
<li>
Perform analyses: link budgets, timing/jitter, signal integrity, power studies (SKM or equivalent).
</li>
<li>
Own prototypes → lab bring-up → test automation → qualification (environmental/EMI).
</li>
<li>
Author technical docs, design reviews, and client deliverables; support proposals and ROMs.
</li>
<li>
Collaborate with firmware/software, cybersecurity, and QA to ensure compliant, testable designs.
</li>
<li>
Mentor junior engineers; contribute to reusable design libraries and best practices.
</li>
</ul>
Minimum Qualifications
<ul>
<li>
BS/MS in Electrical, Systems, or Computer Engineering (or related).
</li>
<li>
6+ years designing hardware or systems for aerospace/defense or similarly regulated domains.
</li>
<li>
Hands-on with RF or high-speed digital, embedded interfaces (SPI/I²C/UART, Ethernet), and power.
</li>
<li>
Proficiency with at least two: Altium/OrCAD, MATLAB/Python, LabVIEW/PyTest, SPICE/ADS, SKM.
</li>
<li>
Requirements &amp; V&amp;V discipline (DOORS/Jama), configuration control, and design documentation.
</li>
<li>
Strong lab skills: scopes, VNAs, spectrum analyzers, logic analyzers; DFM/DFT awareness.
</li>
<li>
U.S. person per ITAR; eligibility for DoD clearance (active clearance is a plus).
</li>
</ul>
Nice to Have
<ul>
<li>
Spread-spectrum/waveform design, SDR, GNSS, or secure comms.
</li>
<li>
Safety/airworthiness standards (DO-160/254/178C) or MIL-STD-461/810 experience.
</li>
<li>
Cybersecurity-aware design and secure boot/TPM familiarity.
</li>
<li>
Embedded C/C++ or Python for test automation; CI/CD and hardware-in-the-loop.
</li>
<li>
Medical/biomedical device exposure (IEC 60601) is a bonus.
</li>
</ul>
Work Setup &amp; Benefits
<ul>
<li>
Hybrid: ~2–3 days/week on-site in San Diego; occasional client site visits.
</li>
<li>
Health, dental, vision; PTO and holidays; 401(k) match; annual training/certification budget.
</li>
<li>
Hardware/lab resources, strong mentorship, and impact on real programs.
</li>
</ul>
Company DescriptionHeinze Consultants LLC (San Diego, CA) is a PE-led engineering consultancy for mission-critical aerospace, defense, and biomedical programs. Founded in 2016, we deliver electrical/RF systems (incl. spread spectrum), AI/ML, cybersecurity, and software. We execute with DOORS requirements traceability and SKM power modeling, pairing hard problems with mentorship on projects of national significance. 
<h3>Company Description</h3>
Heinze Consultants LLC (San Diego, CA) is a PE-led engineering consultancy for mission-critical aerospace, defense, and biomedical programs. Founded in 2016, we deliver electrical/RF systems (incl. spread spectrum), AI/ML, cybersecurity, and software. We execute with DOORS requirements traceability and SKM power modeling, pairing hard problems with mentorship on projects of national significance.

Senior Systems/Electrical Engineer (Aerospace & Defense)

<h3>Job Description</h3>
Job Description
Job Description: R&amp;D Quality Engineer II
Position: R&amp;D Quality Engineer II
Location: Charlotte, NC
Department: Quality/R&amp;D
Work Location: FULL TIME ONSITE 
Reports to: Quality Assurance Manager
Company Overview:
At Aptyx, a new name backed by 70 years of expertise, we bring together the aptitude and excellence of more than a dozen companies with decades of experience helping customers in the life sciences and other demanding industries solve complex manufacturing problems with confidence so they can create more good things in the world. We are committed to delivering high-quality products and services to our customers worldwide. We are seeking a talented Quality Technician to join our dynamic team and contribute to our mission of excellence and innovation.
Job Summary:
The R&amp;D Quality Engineer II will be responsible for supporting the R&amp;D quality team as a project team leader supporting design and development of medical devices. This role involves reviewing and advising design history file (DHF) documentation, influencing R&amp;D project teams to adopt a "quality first" mindset, supporting engineering testing through review of protocols and reports, driving resolution of quality activities such as NCRs and CAPAs for R&amp;D projects, and providing excellent customer service for quality assurance-related topics. The ideal candidate will have a strong technical background, strong interpersonal and leadership skills, a detail-oriented nature, and a passion for collaboration with cross-functional teams.
Key Responsibilities:
<ul>
<li>Quality Management System: Responsible for following and advising improvements to the Aptyx quality management system, including all applicable SOPs.</li>
<li>Quality Record Review: Perform detailed review of quality documentation such as device history records and incoming inspection reports to assure quality of materials, components, and medical devices as needed. Effectively train lower level QA staff to review records with a similar level of detail.</li>
<li>Design History File Documentation Review: Perform detailed review and provide input to the creation of design history file (DHF) documentation such as user needs, engineering specifications, design verification test documentation, drawings, material specifications, and planning documents.</li>
<li>Risk Management Support: Provide support as a team member and reviewer for risk management activities such as FMEA.</li>
<li>Quality Activity Management: Support timely execution of quality activities such as CAPAs and NCRs as champion of the activities. Effectively delegate tasks to other team members.</li>
<li>Data Analysis: Use data analysis and statistical techniques to plan sample sizes and analyze testing results for R&amp;D testing such as Design Verification and Validation. </li>
<li>Technical Support: Provide technical support to quality inspections, develop inspection process improvements, and training quality inspectors. </li>
<li>Metrology Support: Provide metrology support for R&amp;D projects by performing inspections using CMM, vision system, and other similar measurement equipment.</li>
<li>R&amp;D Build Support: Provide support for R&amp;D builds by analyzing nonconforming conditions and providing feedback to quality inspectors as they work through inspections.</li>
<li>Customer Support: Participate in meetings with customers to represent Aptyx project teams and provide input on quality-related topics. Influence the team to adopt a "quality first" mindset.</li>
<li>Engineering Testing Support: Assist with design and validation (including gauge R&amp;R) of engineering benchtop and inspection test methods supporting design verification, process validation, process verification, proof of concept, and lot release testing as required.</li>
<li>Training and Development: Develop and deliver training for local quality inspection teams on R&amp;D quality inspections to ensure that engineering requirements for devices are met and engineering's intentions are understood by inspectors. Train R&amp;D engineers on requirements of the quality management system and other external requirements. </li>
<li>Supplier Management: Communicate with suppliers to resolve quality issues, drive improvements, and support release of materials in a timely manner. </li>
<li>Sterilization Support: Provide input to quality documentation surrounding routine sterilization of product and product-specific documentation related to validation of sterilization processes. </li>
<li>Audit Support: Provide direct support for internal and external audits of Aptyx quality management system, facility, and design and development projects (occasionally as lead auditee as required by management). </li>
</ul>
Qualifications:
<ul>
<li>Education: Bachelor's degree in mechanical engineering, biomedical engineering, materials science, physics, or a related field. </li>
<li>Experience: 3-5 years' professional experience in the field of quality engineering. Medical device industry experience or experience in another similarly regulated industry preferred. Experience with ISO and FDA compliant quality systems preferred. Audit experience preferred.</li>
<li>Technical Skills: Strong knowledge of ISO 13485 quality management systems, inspection processes, measurement equipment, statistical techniques, and quality documentation. Proficiency in CAD software and data analysis software such as Minitab preferred. Lean/Six-Sigma background preferred.</li>
<li>Documentation Skills: Ability to consistently produce attributable, legible, contemporaneous, original, and accurate documentation that complies with good documentation practices.</li>
<li>Problem-Solving: Excellent analytical and problem-solving skills, with the ability to identify root causes and implement effective solutions.</li>
<li>Communication: Strong communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment. Strong leadership skills and ability to positively influence team mindset.</li>
<li>Travel: Travel is not required for this role.</li>
</ul>
Benefits:
<ul>
<li>Competitive salary and performance-based bonuses</li>
<li>Comprehensive health, dental, and vision insurance</li>
<li>Retirement savings plan with company match</li>
<li>Paid time off and holidays</li>
<li>Professional development and training opportunities</li>
<li>Relocation assistance (if applicable)</li>
</ul>

R&D Quality Engineer II (MEDICAL DEVICE)

<h3>Job Description</h3>
Job DescriptionDescription:
Job Brief
We are seeking an experienced Sr. Design Engineer to provide leadership support to our Spinal Hardware Products team within the R&amp;D department. The Senior Design Engineer will be responsible for the design, development, verification and validation of new and existing products for our spinal hardware portfolio. This role requires a strong technical background in mechanical engineering, desire to grow in leadership and the ability to collaborate effectively across teams. The Sr. Design Engineer will play a pivotal role in driving innovation, ensuring product quality, and meeting regulatory requirements in the spinal medical device sector.
 
Responsibilities
<ul>
<li>Primary leader of assigned product development and sustaining projects.</li>
<li>Collaborate with cross-functional teams including R&amp;D, Quality Assurance, Manufacturing, and Regulatory Affairs to achieve project goals and timelines.</li>
<li>Execute on the design, development, verification, and validation of new products, ensuring alignment with market needs and regulatory requirements.</li>
<li>Execute detailed mechanical component and assembly CAD models.</li>
<li>Generate detailed product drawings and component specifications.</li>
<li>Manage design transfer activities from R&amp;D to manufacturing, optimizing processes and ensuring scalability.</li>
<li>Manage and prioritize sustaining engineering efforts for existing products, addressing design improvements, and manufacturing optimizations.</li>
<li>Implement corrective actions and continuous improvement initiatives based on post-market feedback and quality data.</li>
<li>Ensure compliance with FDA regulations (e.g., 21 CFR Part 820) for medical devices.</li>
<li>Collaborate with Regulatory Affairs to support regulatory submissions.</li>
<li>Evaluate and recommend technologies, tools, and resources necessary for product development and sustaining activities.</li>
</ul>
Requirements:
Qualifications
<ul>
<li>Minimum B.S. degree in Mechanical Engineering, Biomedical Engineering, or related field.</li>
<li>Minimum 5 years of experience in engineering roles within the medical device industry.</li>
<li>Strong background in medical device product development, including design, testing, and manufacturing processes.</li>
<li>Knowledge of materials selection, manufacturing processes (e.g., machining, casting), and product lifecycle management.</li>
<li>Experience in analytical processes (e.g., FEA, numerical modeling, Risk Analysis).</li>
<li>Experience with contract manufacturer development and working relationships.</li>
<li>Experience with implantable medical devices or surgical instrumentation.</li>
<li>Familiarity with design for manufacturability (DFM) and design for assembly (DFA) principles.</li>
<li>Excellent organizational and communication skills.</li>
<li>Ability to prioritize tasks and manage multiple projects effectively.</li>
<li>Hands-on, driven work ethic.</li>
</ul>
Physical Requirements
This is largely a sedentary role; prolonged periods sitting at a desk and working on a computer. This would require the ability to lift files, open filing cabinets and bend or stand as necessary.
 
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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