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<h3>Job Description</h3>
Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBioProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.
Job Scope:
Every day, Genscript's Field Service Engineer helps our customers to tackle issues that enable scientists to make research easy. Through our work, we deliver insights and provide support that keep labs running smoothly and more efficiently. Join our team to be a part of this exciting work!
As a Field Service Engineer for Genscript, you will work at a variety of labs, so having an appetite for continuously learning about instruments and troubleshooting is key. The ability to help with solving customer problems and a dedication to deliver strong customer service is how you will build customer success.
Please note that this role is required to be based onsite in Piscataway, NJ when not traveling for customer visits. The estimated salary range depending on experience level is $80,000 - $100,000 base salary.
Responsibilities:
You will be responsible for supporting our customers with on-site installation, implementation, maintenance and repair of multiple solutions. Our products include hardware, software, and consumables.
<ul>
<li>Installs and optimizes hardware/software products at customer sites.</li>
<li>Respond to internal and external customer needs by providing testing, repair, installation, upgrade, and preventive maintenance activity on service experience with automation and liquid handling.</li>
<li>These devices contain a large amount of electro-mechanical, pneumatic, systems as well as computer hardware and software.</li>
<li>Diagnoses and resolves product performance problems.</li>
<li>Contact customers in a timely manner and schedules service efficiently Performs maintenance and repairs.</li>
<li>Ensures customer happiness by advising customers on preventive maintenance and configurations, which may impact product performance.</li>
<li>Connect with manager and sales team to ensure customer needs and expectations are clearly understood and met.</li>
<li>Provide promptly feedback to the manufacturing and R&amp;D team concerning performance anomalies encountered as required.</li>
<li>Proactively responds to potential equipment issues to prevent unplanned interruption of customers' business.</li>
<li>Responsive to customer requests for service and communicate proactively before, during and after service.</li>
<li>Document time and expenses in a timely manner as required as requested by manager.</li>
<li>Serves as an internal resource on technical issues and manages product customer concerns. Collaborates with teams such as Support, Sales, Marketing and R&amp;D to provide solutions to customers.</li>
</ul>
Qualifications:
<ul>
<li>Bachelor's or master's degree within the science field - e.g., mechanical or electrical is a plus.</li>
<li>2+ years of experience in a similar position. Hands on and troubleshooting experience.</li>
<li>Must have experience working with Automation and liquid handling.</li>
<li>Previous instrumentation maintenance, wire diagram, electromechanical, preventative maintenance, biomedical equipment or laboratory repair instrument repair experience is a plus.</li>
<li>Experience with the Genscript product is desired but not crucial.</li>
<li>Verbal and written communication is clear, respectful, and timely.</li>
<li>Travel: 50% travel per week in the field visiting customers</li>
<li>Able to work independently</li>
<li>Able to lift 40 lbs.</li>
</ul>
#LI-EB1
#GS
GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.
Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Field Service Engineer, CPBU

<h3>Job Description</h3>
Job Description
Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines &amp; Values:
<ul>
<li>We empower and support our colleagues</li>
<li>We commit to client success at every turn</li>
<li>We have the courage to do the right thing</li>
<li>We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.</li>
<li>We constantly acquire new skills and learn from our experiences to enhance our collective expertise</li>
</ul>
CQV Engineer Responsibilities (Typical):
<ul>
<li>Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis</li>
<li>Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release</li>
<li>Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader</li>
<li>Running test scripts and documenting results</li>
<li>Adherence with project schedule for all assigned activities</li>
<li>Maintaining clear, detailed records qualification and validation</li>
<li>Documenting impact and risk assessments as part of a team</li>
<li>Completing user interface testing, software verification, and complete alarm testing on automated systems</li>
<li>Developing, reviewing, and executing testing documentation</li>
<li>Making recommendations for design or process modification based on test results when executing test scripts</li>
<li>Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment</li>
<li>General understanding of capital equipment implementation and process knowledge</li>
<li>Understanding validation documents, URS, IQ, OQ, PQ</li>
<li>Verifying system drawings including ability to review and as-built P&amp;IDs (piping and instrumentation drawings) and I&amp;C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer</li>
</ul>

Requirements:
<ul>
<li>Must be able to meet onsite work requirements in Holly Springs, NC</li>
<li>Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)</li>
<li>2-4 years of relevant industry experience</li>
<li>Proficiency using PC and Microsoft Office tools</li>
<li>Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms</li>
<li>Ability to work as part of a team</li>
<li>Strong problem-solving and critical thinking skills</li>
<li>Excellent organizational and time management skills</li>
<li>Strong attention to detail</li>
<li>GMP and Good Documentation Practice training (may be completed at onboarding)</li>
<li>Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)</li>
<li>Basic skills with EXCEL and PowerPoint</li>
<li>Strong interpersonal skills and clear communication capabilities</li>
</ul>
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
National (US) Range$65,000—$104,439 USD
Benefits
Why Choose Verista?
<ul>
<li>High growth potential and fast-paced organization with a people-focused culture</li>
<li>Competitive pay plus performance-based incentive programs</li>
<li>Company-paid Life, Short-Term, and Long-Term Disability Insurance.</li>
<li>Medical, Dental &amp; Vision insurances</li>
<li>FSA, DCARE, Commuter Benefits</li>
<li>Supplemental Life, Hospital, Critical Illness and Legal Insurance</li>
<li>Health Savings Account</li>
<li>401(k) Retirement Plan (Employer Matching benefit)</li>
<li>Paid Time Off (Rollover Option) and Holidays</li>
<li>As Needed Sick Time</li>
<li>Tuition Reimbursement</li>
<li>Team Social Activities (We have fun!)</li>
<li>Employee Recognition</li>
<li>Employee Referral Program</li>
<li>Paid Parental Leave and Bereavement</li>
</ul>
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. 
For more information about our company, please visit us at Verista.com

5832- CQV Engineer / Validation Engineer 2

<h3>Job Description</h3>
Job Description
Riverpoint Medical in Northeast Portland is hiring a Development Engineer I. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Riverpoint Development Engineer I will develop systems, processes, methodologies as well as product development to enhance our product offering. Transforming concepts into prototypes for testing, validation, and improvement for production.
We Are Seeking an Individual who:
• Thrives in an environment where technical learning is hands on. 
• A desire to be creative, improve processes and find solutions for the next generation of medical devices.
• Is detailed oriented to plan, execute, and document their work through reports and data analysis. 
• Enjoys a team model where all individuals are encouraged for personal growth.
• Is excited at the opportunity to be a technical project leader interacting with our customers. 
Responsibilities:
• Plan, conduct, and manage design and development projects for medical devices in support of the company's strategic plan. 
• Leads to the development of new patient specific products and associated manufacturing processes.
• Maintain productive and respectful dialogue with customers to determine product requirements and ensure customer needs are met. 
• Determines project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.
• Completes technical studies and prepares cost estimates.
• Engage outside contracting services in support of project needs, i.e., analytical laboratories, consultants, material suppliers and equipment suppliers. Build effective relationships with these resources to meet delivery and budgetary goals.
• Research and understand device functionality, device patents, and clinical use.
• Design and develop products in full compliance with the Riverpoint Medical Design Control requirements per SOP820.030, and maintain design files for company products, including testing, testing reports, verification, validation, design files, and design reviews. 
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. 
Requirements: 
• Bachelor’s degree in mechanical, materials science, chemical, or biomedical engineering or similar or equivalent work experience
• 1-3 years’ experience working in a controlled manufacturing or development environment.
Preferred Qualifications:
• Experience working in an FDA regulated industry/field, or similar.
• Exposure to the FDA 510(k) process or other regulatory submissions.
• Experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development.
We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus!
 Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Development Engineer I

<h3>Job Description</h3>
Job DescriptionPOSITION SUMMARY Were seeking a proactive and detail-oriented Quality Engineer to ensure that our product development processes meet quality, regulatory and company standards. You will play a pivotal role in design quality and development lifecycle, supporting cross-functional teams, and helping to shape our robust Quality Management System (QMS) to meet our business requirements. Key Responsibilities 
<ul>
<li>Serve as the design quality engineer taking development projects from concept through commercialization.</li>
<li>Ensure compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.</li>
<li>Lead and support design control activities: risk management (ISO 14971), design inputs/outputs, verification and validation, design reviews, and design history file (DHF) maintenance.</li>
<li>Develop and implement quality plans, test strategies, and protocols for new product development.</li>
<li>Drive root cause analysis and corrective/preventive actions (CAPA) related to product design and development.</li>
<li>Monitor and analyze quality metrics and trends. Support development and continuous improvement of the Quality Management System.</li>
<li>Participate in technical design reviews and project phase reviews.</li>
<li>Review and approve Engineering Change Orders (ECOs), test protocols, and technical documentation.</li>
<li>Collaborate with Product Management, Engineering, R&amp;D, Regulatory, Manufacturing, Customer Success and Clinical teams to ensure quality is integrated throughout the product lifecycle.</li>
<li>Support internal, external audits and regulatory inspections.</li>
<li>Provide Quality representation during problem resolution supporting a risk-based approach for processes.</li>
<li>Establish and maintain metrics and reports for design quality performance.</li>
</ul>
Key Skills/Abilities 
<ul>
<li>Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR.</li>
<li>Demonstrated ability to interpret engineering drawings, specifications, and technical documents.</li>
<li>Strong verbal and written communication skills, ability to present issues, plans, and objectives</li>
<li>Strong documentation, analytical, and organizational skills</li>
<li>Skilled in risk management techniques, root cause analysis, and statistical tools.</li>
<li>Excellent communication and organizational skills with the ability to work independently and cross-functionally.</li>
<li>Certified Quality Engineer (CQE) or other relevant certifications such as Six Sigma preferred.</li>
</ul>
Education/Experience 
<ul>
<li>Bachelors degree in Engineering, Biomedical Engineering, or related technical discipline.</li>
<li>Minimum 5 years of experience in Quality Engineering within the medical device industry.</li>
<li>Experience working in a smaller, more agile environment is a strong plus.</li>
<li>Experience working with contract manufacturers and suppliers.</li>
<li>Experience with tools such as FMEA, CAPA, Root Cause Analysis (5 Whys, Fishbone), and control charts.</li>
<li>Experience with software as a medical device (SaMD) or digital health technologies preferred.</li>
</ul>
Location: Waltham, MA 02451, 4-5 days onsite required Employment Type: Full-Time Reports To: Director of Quality and Regulatory We offer competitive salary and benefits! 401(k) plans &amp; matching, Health, Dental &amp; Vision Insurance, Short &amp; Long Term Disability, Parental Leave, Life Insurance, Stock Options, EAP &amp; voluntary benefits. ABOUT CONVERGENT DENTAL: Convergent Dental, Inc. is a privately owned dental equipment and technology company. Our high-energy, high-tech culture is experiencing rapid growth and looking for new team members who can grow with us. Our flagship product, Solea, is the only CO2 laser to be cleared by the FDA for all-tissue indications and delivers an anesthesia-free, blood-free, suture-free experience. Solea is a true breakthrough in dental laser technology that offers a completely different experience for both dentists and patients when compared to traditional instruments or any earlier laser treatment. Soleas speed and precision is a result of its wavelength and computer controls that are unique to Convergent Dental, Inc. We are a high-energy team, and looking for new members who can grow with us. Our culture is fast paced, collaborative, and a roll up your sleeves entrepreneurial environment. We are all working towards forever changing how people think about going to the dentist. If you are a motivated, career-oriented individual, Convergent Dental is the place for you! Convergent Dental is committed to developing a diverse and talented team. All candidates are encouraged to apply. If you are excited about this role but are unsure whether you meet 100% of the requirements, we encourage you to inquire and/or apply.

Quality Engineer

<h3>Job Description</h3>
Job Description
What are we looking for (Position Summary): 
To provide industry exceptional customer support with a high degree of customer satisfaction, technical expertise, business acumen and timeliness. This position will work closely with Sales, Marketing, Client Service and QA in regard to product complaint evaluation as well as many other areas of the company.
Essential Duties and Responsibilities:
~80% of time provides technical support to internal and external customers through the following channels:
<ul>
<li>Call/Email/Onsite</li>
<li>Installation and Training</li>
<li>Maintenance Visits</li>
<li>Generation of technical product content; e.g. technical notes, videos, manuals, etc.</li>
<li>Directing customer feedback to internal stakeholders</li>
</ul>
~20% of time performing the following duties:
<ul>
<li>Engineering Support; e.g. system testing, manufacturing training, etc.</li>
<li>Marketing Support; e.g. represent voice of customer, participate in cross-functional team activities, etc.</li>
<li>Alpha/Beta site Support</li>
<li>Services Support (Data &amp; Validation, Surgical, or IACUC)</li>
</ul>
Skills and Abilities Required: 
<ul>
<li>Well-developed written and verbal communication skills enabling the individual to confidently convey critical and complex information via phone, email, and in person.</li>
<li>Ability to communicate directly with customers in a manner that provides them continued confidence in DSI.</li>
<li>Engineering technical ability to understand and support DSI's broad offering of products.</li>
<li>Aptitude for problem solving and continuous improvement proficiency and application.</li>
<li>Maintains awareness of policies, procedures and work instructions as identified in DSI training programs. Individuals performing activities that affect quality must have the expertise, skills and knowledge to carry out their role.</li>
<li>Operating systems: knowledge in Windows 7, 10 </li>
<li>Programing: C++, C#, HTML/CSS, Java, Python</li>
</ul>
Education and Experience Required:
<ul>
<li>BS in electrical engineering, biomedical engineering, software related to life sciences (physiology), or computer science degree with emphasis on instrumentation or relevant experience. </li>
<li>2 years' experience minimum.</li>
</ul>
Bonus Skills &amp; Experience
<ul>
<li>Previous Technical Support Experience</li>
<li>Knowledge of networking system (DHCP, TCP, firewall setup)</li>
</ul>
 Job Posted by ApplicantPro

Technical Support Engineer

<h3>Job Description</h3>
Job Description
Overview
Now Hiring Field Service Engineer Ultrasound!Location: Washington, DC*Some regional travel may be required*Salary: Starting at $60,000 annually based on experience. Who We Are:
Tri-Imaging Solutions is at the forefront of medical imaging equipment innovation, specializing in enterprise imaging systems management. We’re committed to delivering cutting-edge solutions and empowering our team with the tools, training, and opportunities to grow. Join our dynamic team and play a vital role in advancing healthcare technology.
Why Join Us (Benefits):
<ul>
<li>
Highly competitive salary
</li>
<li>
Car/travel reimbursement
</li>
<li>
Continuing diagnostic imaging training (with a path into advanced modalities like CT, MRI, and Cath Lab)
</li>
<li>
Company-paid holidays plus PTO
</li>
<li>
Major medical/dental/vision benefits
</li>
<li>
Recognition/reward program
</li>
</ul>
Position Overview:
We are seeking a motivated Level 1 Field Service Engineer with a primary focus on ultrasound systems. This is an excellent opportunity for early-career professionals with a strong technical foundation who want to expand into other diagnostic imaging modalities over time. The right candidate will receive structured training and mentorship to build expertise across the full spectrum of imaging technology.
What You’ll Do:
<ul>
<li>
Perform installations, calibrations, inspections, and basic repairs on general ultrasound equipment
</li>
<li>
Conduct preventive maintenance in accordance with OEM specifications
</li>
<li>
Use laptop-based diagnostic tools and hand tools to assess and improve system performance
</li>
<li>
Collaborate closely with senior engineers to develop advanced troubleshooting skills
</li>
<li>
Provide excellent customer service while ensuring equipment operates to the highest safety and performance standards
</li>
<li>
Travel to client sites within the assigned territory
</li>
</ul>
What You’ll Need (Requirements):
<ul>
<li>
Associate degree in Biomedical Engineering, Electrical Engineering, or related field, or equivalent work experience
</li>
<li>
1–2 years of hands-on experience as a biomedical or ultrasound service technician
</li>
<li>
Strong mechanical aptitude and diagnostic skills
</li>
<li>
Eagerness to learn other imaging modalities such as CT, MRI, and Cath Lab
</li>
<li>
Excellent communication and teamwork abilities
</li>
<li>
Willingness to travel regionally as needed
</li>
</ul>

Field Service Engineer Ultrasound

<h3>Job Description</h3>
Job Description
We are currently seeking a Lead Scientist / Engineer with a PhD in Systems &amp; Control, Biomedical Engineering, Applied Mathematics, or a related quantitative field, and 5–6+ years of experience in applied modeling and estimation. This role will function as a senior member of the company’s algorithm team. It will involve designing and implementing Etiometry’s next-generation physiologic risk and treatment-prediction algorithms. The position will require close collaboration with Etiometry’s data science, product, and clinical teams to translate physiologic and clinical requirements into real-time decision support tools deployed in the ICU.
Responsibilities
<ul>
<li>
Lead the design, implementation, and validation of algorithms that predict patient trajectories and responses to interventions (e.g., fluids, vasoactives, ventilator changes).
</li>
<li>
Extend Etiometry’s existing ODE-based physiologic models with advanced estimation methods (e.g., Kalman filters, Bayesian inference, particle filters).
</li>
<li>
Integrate data-driven approaches (e.g., neural networks, probabilistic ML, hybrid mechanistic/ML frameworks) with classical physiology-based models.
</li>
<li>
Translate physiologic and clinical requirements into quantitative risk indices for FDA-regulated software.
</li>
<li>
Work with real-world ICU data, including physiologic waveforms, vital signs, and laboratory values.
</li>
<li>
Mentor junior scientists and collaborate with engineers, clinical experts, and regulatory affairs to bring models from research → cleared product.
</li>
</ul>
Basic Qualifications
<ul>
<li>
PhD in Systems &amp; Control, Biomedical Engineering, Applied Mathematics, Electrical/Mechanical Engineering, or a related field.
</li>
<li>
5–6+ years of experience (industry or postdoctoral) in applied modeling, estimation, or control systems.
</li>
<li>
Strong background in dynamical systems &amp; ODE/PDE modeling.
</li>
<li>
Strong background in state estimation techniques (Kalman filters, stochastic processes, Bayesian methods).
</li>
<li>
Working knowledge of machine learning (neural networks, probabilistic ML, data-driven system identification).
</li>
<li>
Proficiency in scientific computing in Python (NumPy, SciPy, PyTorch, TensorFlow).
</li>
<li>
Strong communication and organization skills.
</li>
<li>
Proven ability to work in cross-disciplinary teams and translate theory into applied solutions.
</li>
</ul>
Desired Qualifications
<ul>
<li>
Experience working with clinical monitoring data (ICU waveforms, vital signs, laboratory data, EHR integration).
</li>
<li>
Familiarity with computational physiology or biomedical modeling.
</li>
<li>
Knowledge of medical device software lifecycle (IEC 62304, FDA 510(k)).
</li>
<li>
Experience mentoring junior scientists or leading research projects.
</li>
</ul>
About Etiometry
Etiometry is the market leader in predictive analytics for the Intensive Care Unit. Our system leverages real-time patient data to provide clinicians with actionable information that improves care for the most vulnerable patients. In use at some of the best medical institutions across three continents, the Etiometry Platform has a proven track record in improving outcomes while reducing hospital costs. Our next generation of algorithms will go beyond monitoring risk to forecasting how treatments will affect patient physiology — giving clinicians foresight to guide critical interventions. By joining Etiometry, you will be at the forefront of clinical innovation, working with a passionate team of engineers and scientists with the mission of transforming the delivery of critical care. You will become an integral part of a dynamic team whose work will directly impact patients worldwide and shape the future of ICU analytics.

Lead Algorithm Scientist Engineer

<h3>Job Description</h3>
Job Description
Are you a mechanical maestro ready to unleash your expertise? At BDC Laboratories, we invite you to immerse yourself in an exhilarating role as a Full-Time Product Evaluations Engineer III onsite in Wheat Ridge, CO. This isn’t just any gig; it’s an opportunity to innovate and solve real-world problems, all while collaborating with a vibrant team that values customer satisfaction above all.
As you dive into engaging projects that drive the biotech industry forward, you'll enjoy a competitive salary ranging from $95,000 to $112,000. Here, your ingenuity and keen eye for excellence will be recognized, not just encouraged. The thrill of working in a dynamic, energetic environment awaits you!
You will be provided great benefits such as Medical, Dental, Vision, 401(k), Health Savings Account, and Paid Time Off. Don’t miss the chance to be at the forefront of biotechnology, where every day is a new adventure. Elevate your career with us today!
Let us introduce ourselves
Biomedical Device Consultants &amp; Laboratories (<a href="http://www.bdclabs.com" target="_blank">www.bdclabs.com</a>) is a fast-growing company that offers comprehensive medical device testing services, designs verification test equipment, and produces silicone mock vessels to the medical device community in support of domestic and international regulatory submissions and approvals. Our primary focus is cardiovascular technologies such as endovascular stents, prosthetic heart valves, and catheters. As a small company, BDC's environment is fast-paced, dynamic, challenging, and rewarding.
Your day to day as a Product Evaluations Engineer III
As a Full-Time Product Evaluations Engineer III at BDC Laboratories, your mission is to ensure that every piece of equipment meets the rigorous demands of our biotech studies. You’ll assess the suitability of equipment for data acquisition, ensuring compliance with protocol specifications. Your expertise will keep our laboratory inspection-ready, as you guarantee all equipment is designed for optimal performance, adequately cleaned, and meticulously maintained. You'll lead the way in establishing innovative test methods, preparing meticulous protocols, and maintaining a contamination-free environment.
Each data entry you record will enhance the integrity of our research, as you diligently verify and analyze experimental data. Additionally, you will play a key role in supporting our Quality Management System and participating in audits, all while setting an exemplary standard for your colleagues. This position is not just about maintaining excellence; it's about driving innovation in a fun, high-performance culture.
Requirements for this Product Evaluations Engineer III job
To thrive as a Full-Time Product Evaluations Engineer III at BDC Laboratories, you’ll need a robust toolkit of skills and experiences. A minimum of a Bachelor’s Degree in engineering or a science-based field, coupled with relevant years of experience, establishes your foundational expertise. Familiarity with quality system requirements like ISO 17025 and 21 CFR Part 58 is preferred, while knowledge of ISO 13485 and 21 CFR Part 820 will set you apart. Your analytical and problem-solving prowess will be crucial, allowing you to perform statistical analyses and interpret technical regulations effectively. Strong verbal and written communication skills are essential for drafting clear protocols and presenting information to both managers and team members.
Additionally, your ability to mentor and manage fellow engineers will contribute to a dynamic and collaborative team environment. Embrace this opportunity to lead with integrity in a forward-thinking biotech space!
Knowledge and skills required for the position are: 
<ul>
<li>Minimum of a Bachelor’s Degree in an engineering field and 4 years of experience; or minimum of a Master’s Degree in an engineering field and 2 years of experience; or minimum of a Bachelor’s Degree in a science-based field and 6 years of relevant experience; or an Associate Degree with a minimum of 10 years of relevant experience.</li>
<li>Understanding of quality system requirements including ISO 17025 and 21 CFR part 58 is preferred. Experience in 21 CFR Part 820 and Part 11, ISO 13485 and other relevant international standards desirable.</li>
<li>Must be organized with excellent analytical and problem-solving abilities and the ability to perform and report basic statistical analyses.</li>
<li>Ability to read analyze and interpret technical procedures and governmental regulations; along with the ability to effectively present information and respond to questions from managers and team members. Ability to effectively draft protocols and reports.</li>
<li>Ability to define problems, collect data, establish facts and draw valid final conclusions.</li>
<li>Strong verbal and writing skills and good interpersonal and leadership skills.</li>
<li>Proficiency with a Windows environment(Word and Excel) required.</li>
<li>Experience managing other engineers.</li>
</ul>
Get started with our team!
If you feel that this job is what you're looking for, applying is a piece of cake - just follow the instructions on this page. Good luck!
 Job Posted by ApplicantPro

Product Evaluations Engineer III

<h3>Job Description</h3>
Job DescriptionDescription:
 The Process Engineer II is responsible for ensuring the organization is compliant with all applicable regulations and standards in the areas of process validations. In addition, this position leads process change and improvement throughout the different areas of the company, including manufacturing. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to the manufacturing floor. The Process Engineer II makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.
Requirements:
Duties and responsibilities
<ul>
<li>Provide backup support to the Director Research and Development Operations, as needed.</li>
<li>Perform critical review of Process Engineer I project plans and related documents to ensure implementation is accurate and timely.</li>
<li>Independently lead and coordinate cross-functional projects and related resources to ensure completion in a timely manner. Communicate to management of performance against plan.</li>
<li>Perform data and technical presentation reviews as needed.</li>
<li>Understand and apply the applicable regulations and standards for equipment qualification and process validation to ensure compliance.</li>
<li>Statistical and analytical methods to understand processes.</li>
<li>Use LEAN Manufacturing principles to analyze and make recommendations for process optimization and implementation.</li>
<li>Work with other department heads or designees on projects as delineated on project plans to ensure timely completion of projects.</li>
<li>Develop equipment and process validation protocols (IQ, OQ, PQ) and reports as needed.</li>
<li>Lead and perform equipment qualifications and process validations as needed. </li>
<li>Develop and monitor process and equipment metrics to use for optimization analysis.</li>
<li>Develop and implement solutions with minimal supervision.</li>
<li>Comply with FDA and AATB tissue banking standards. </li>
<li>Other duties as assigned.</li>
</ul>
Qualifications
<ul>
<li>BS in Biomedical, Mechanical, Industrial Engineering or other applicable engineering discipline. Advanced degree (Master’s) a plus.</li>
<li>A minimum of 3 years of experience in Tissue Banking, Device, Biologics, or pharmaceutical industry in a relevant engineering role. Leadership experience preferred.</li>
<li>Strong analytical, planning, project management, critical thinking, troubleshooting, and problem-solving skills.</li>
<li>Ability to effectively communicate with multidisciplinary teams. Excellent technical skills and writing.</li>
<li>Strong knowledge of LEAN manufacturing principles preferred. </li>
<li>Strong knowledge of 21CFR 1271 regulations and AATB guidelines.</li>
<li>Highly proficient in project planning software. Microsoft Project preferred.</li>
<li>CTBS certified (or certified within two years of employment). </li>
<li>Strong work ethics. </li>
</ul>
Working conditions
Job requires working in office. Must be willing to work weekends and evening hours, as necessary. Must be willing to accommodate travel, if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing.
 
Physical requirements
Job is one where the incumbent is required to stand for extended periods of time, lift heavy objects, and do repetitive tasks with few breaks while executing engineering plans.
 
Direct reports
Intern
 
Nothing in this job description restricts management’s right to assign or reassign duties and 
responsibilities to this job any time. 
Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.
Vivex Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.

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