Machine Learning Engineer
Project engineer job in Fremont, CA
STAFF AI/ML ENGINEER - HEALTHTECH
$200K-$235K BASE + EQUITY
HYBRID - SUNNYVALE, CA (MON-THU ONSITE, FRI WFH)
Are you passionate about applying AI to improve real-world health outcomes and quality of life for seniors?
THE COMPANY
This early-stage healthtech startup is on a mission to make healthcare more proactive and accessible through AI-driven technology. They're developing an intelligent in-home device designed to improve wellness monitoring and engagement for seniors. The company is growing quickly, with active pilots in the market and a consumer launch on the horizon.
THE ROLE
As the Staff/Principal ML Engineer, you'll collaborate closely with senior leadership to design and deploy machine learning models for real-world applications. You'll play a key role in establishing the company's ML foundation, guiding technical strategy, and mentoring a small team of contributors and partners.
RESPONSIBILITIES
Developing and optimizing models for radar signal processing and real-time inference
Deploying models on the edge using C++ and TensorFlow Lite
Collaborating with firmware and software teams to integrate ML into hardware devices
Establishing best practices and guiding future team growth
YOUR SKILLS AND EXPERIENCE
Strong background in radar or digital signal processing (DSP)
Hands-on experience deploying ML models on edge devices (C++, TensorFlow Lite)
Proficiency with Python, PyTorch, TensorFlow
Experience in firmware or device-level integration
A startup mindset - ownership mentality, curiosity, and hands-on problem-solving
If you're excited about building AI that improves lives and drives meaningful change in healthcare, this is your opportunity to make it happen.
Staff Backend Engineer
Project engineer job in San Francisco, CA
80Twenty is a boutique marketing recruitment agency that connects high-growth companies with exceptional candidates.
Want to build technology that truly moves the needle in healthcare? Join a fast-scaling, profitable healthcare services company - independently grown and not VC-backed - on a mission to make healthcare simpler, smarter, and more human! Our client is a healthcare tech and services company based in San Francisco, combining clinical expertise, operational excellence, and modern engineering to reshape how people experience care. From personalized medication management and transparent pharmacy pricing to community-based chronic care support, we're building a system that empowers both patients and providers.
This is a fully onsite role based in San Francisco, CA. Candidates must be located within 30 miles of San Francisco. The standard schedule is Monday-Friday, 9am-7pm and may vary depending on business needs and role responsibilities.
In this role, you will:
Design, build, and scale backend services that power pharmacy, telehealth, and patient-facing workflows.
Collaborate cross-functionally with product, operations, and pharmacy teams to deliver seamless integrations and reliable systems.
Lead architectural design discussions and set long-term technical direction for the backend stack.
Implement best practices for system reliability, observability, security, and scalability.
Drive operational excellence through CI/CD pipelines, cloud infrastructure (AWS), and container orchestration (Kubernetes).
Mentor fellow engineers and help shape our backend engineering culture.
Optimize system performance and streamline complex data flows across distributed services.
Influence and define standards for how we build, test, and deploy software across the company.
Who You Are
7+ years of backend engineering experience, ideally in fast-moving production environments.
Strong experience with Node.js (TypeScript / JavaScript) and modern backend frameworks.
Deep familiarity with AWS, Kubernetes, CI/CD, and distributed system design.
Adept at owning code from design through deployment - you care about maintainability, reliability, and long-term scalability.
Excellent communicator who enjoys collaborating across disciplines.
Motivated by solving complex real-world problems in healthcare and improving patient outcomes.
Bonus points for experience in healthcare, pharmacy systems, inventory/fulfillment flows, or regulated environments.
Why This Role Stands Out
You'll own high-impact systems that directly affect patient and provider experiences.
You'll shape backend architecture and engineering best practices in a growing company.
You'll join a profitable, non-VC-backed organization focused on long-term sustainability.
You'll work in-person with an ambitious, mission-driven team in downtown San Francisco.
Competitive compensation, equity opportunities, and strong benefits designed to help you thrive.
This is a great opportunity to be a key member of the engineering team, taking technical ownership of our pharmacy platform's core backend systems. Your work will directly power real-time healthcare operations and improve access to care. If you're excited to apply your engineering expertise to meaningful healthcare infrastructure - and want to join a company that values autonomy, sustainability, and impact - we want to hear from you!
Base salary: $250k-300k DOE + generous equity and benefits
Machine Learning Engineer - Post Training
Project engineer job in San Francisco, CA
A stealth-stage venture backed by Lux Capital (investors in DeepMind and OpenAI) is developing frontier-scale AI systems for high-impact applications in human health and decision-making. The team is applying LLMs and multimodal agents to complex real-world problems where precision, safety, and interpretability matter.
This role focuses on post-training workflows for large models, including RLHF, reward modeling, and evaluation. Ideal candidates have experience aligning agent behavior with nuanced goals in high-stakes environments. The position involves close collaboration with research and product teams to define evaluation criteria, build scalable RL pipelines, and ship production-grade systems.
Ideal Experience:
Designing and scaling RL environments for LLMs
Building high-quality evaluation pipelines for frontier models
Collaborating with domain experts to define evaluation tools and metrics
Crafting training datasets and reward functions using LLMs and/or human feedback
Training large models with RLHF, DPO, or instruction tuning
Translating abstract requirements into concrete evaluation frameworks and agent behaviors
Bonus:
End-to-end experience shipping ML systems in production
Prior startup or zero-to-one experience
Experience with PyTorch, JAX, or other modern ML frameworks
Familiarity with multi-cloud infrastructure and distributed compute
While familiarity with biomedical data is welcome, candidates from non-bio backgrounds are strongly encouraged to apply. The team values engineering excellence and creativity over domain-specific experience.
Mechanical Patent Associate 21269 San Francisco
Project engineer job in San Francisco, CA
Qualifications
Patent preparation and prosecution experience, either in-house or as outside counsel, specifically in the mechanical arts (e.g., recreational vehicles, industrial devices, medical devices, and consumer devices)
A BS degree in mechanical engineering is preferred, although candidates with other degrees will be considered
Additional legal, industry, and/or academic experience in mechanical engineering or related fields is desirable
Active bar admission in Oregon or Washington
Registered to practice before the USPTO
Strong time management and organizational skills, including demonstrated ability to take ownership for, and efficiently manage, a large docket including meeting internal and external deadlines
Familiarity with operations of large organizations with established patent programs, including international organizations
Strong work ethic and commitment to being responsive to client needs
Excellent writing, communication and interpersonal skills
Ability to collaborate and work effectively with a variety of internal and external stakeholders
Demonstrated ability working independently
About Vanguard-IP
Vanguard Intellectual Partners (Vanguard-IP) specializes in the placement of IP/Patent professionals nationwide.
Our sole focus on intellectual property enables us to more deeply understand our clients' technical needs, and our candidates' individual talents and career interests. Our broad network of long-term client relationships gives us a competitive edge.
Our recruiters all have 10+ years of IP recruiting experience, and an exceptional record of success. We have superior knowledge of the IP job market, and offer trusted career advice for our candidates. We also have the resources and high-level contacts to get your resume noticed by the people who matter.
We look forward to speaking with you, and learning more about what you are seeking in your next opportunity.
Confidentiality
At Vanguard-IP, we respect the confidentiality of every candidate who contacts us. Furthermore, we will always obtain expressed authorization before submitting your resume to any of our clients.
Should you have an interest in exploring opportunities in another location, we have hundreds of openings in other markets. Please apply now and our team would be happy to review your information for this or other openings in your location of interest.
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R&D Engineer
Project engineer job in Mountain View, CA
At Expanding Innovations, Inc. (EI), we're redefining what's possible in spinal fusion. As a fast-growing leader in non-screw-based expandable cage technologies, we're committed to solving the most complex clinical challenges faced by today's spine surgeons-ultimately improving patient outcomes through innovation.
We're looking for a driven and experienced R&D Engineer to join our collaborative, fast-paced team and help shape the future of spinal device technology.
Position Overview
This on-site role is ideal for an engineer who thrives on innovation, cross-functional collaboration, and seeing ideas through from concept to commercialization. You'll lead one or more product development projects while contributing to a broader portfolio of initiatives across the R&D team.
Key Responsibilities
Project Leadership
Lead one or more product development projects from concept through launch.
Collaborate with cross-functional teams (Product Management, Regulatory, Quality, Manufacturing) to meet project milestones on time and within budget.
Maintain clear project plans and Design History Files (DHF) in compliance with FDA and ISO 13485 standards.
Design & Development
Drive the technical design process, including prototyping, testing, and validation.
Apply engineering principles to optimize product performance, usability, and manufacturability.
Conduct geometric tolerancing analysis and design optimization to enhance the end-user experience.
Participate in and lead product testing (feasibility, ASTM, validation, etc.).
Risk & Compliance
Develop and manage risk documentation (DFMEA, PFMEA, UFMEA) in collaboration with the team.
Ensure adherence to design controls and regulatory requirements throughout the development lifecycle.
Innovation & IP
Contribute to a culture of innovation by generating new ideas, patents, and intellectual property.
Stay current on industry trends, competitive technologies, and emerging materials.
Qualifications
Required:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field (Master's or Ph.D. preferred).
5+ years of mechanical design experience in the medical device industry.
Proven track record of leading complex product development projects.
Deep understanding of spinal anatomy, biomechanics, and surgical techniques.
Proficiency in CAD (e.g., SolidWorks), FEA, and other engineering tools.
Strong knowledge of FDA regulations, ISO 13485, and ASTM testing standards.
Excellent communication skills-able to convey complex technical concepts to diverse audiences.
Strong interpersonal skills and a collaborative mindset.
Authorized to work in the U.S. (Visa sponsorship is not available for this role).
Preferred:
A strong preference for work experience in the spine surgical device space, most notably interbody fusion procedures.
Experience with expandable interbody fusion devices.
Expertise in GD&T, 1D tolerance analysis, and 3D modeling/analysis.
Familiarity with sterile packaging and cleanroom manufacturing.
Knowledge of cost-of-goods (COG) optimization through design for manufacturability.
Hands-on experience with manufacturing methods such as machining, injection molding, sheet metal forming, and thermoforming.
Salary Range: Expanding Innovations, Inc. (EI) complies with all state and federal wage and hour laws. Exact compensation may vary based on candidate's qualifications, experience, and exact location. $110,000 to $145,000 Full-Time Annual Salary, with annual bonus opportunities and stock incentives.
Why Join Us?
Be part of a mission-driven team transforming spinal surgery.
Work on cutting-edge technologies with real clinical impact.
Grow your career in a dynamic, innovation-focused environment.
Verification Validation Engineer, Medical Device
Project engineer job in Fremont, CA
*** This is not a software role***
The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons
Responsibilities
Design Verification & Validation:
Plan, execute, and document design verification and validation (V&V) activities to support product development and ensure compliance with internal and regulatory requirements.
Technical Support:
Provide engineering support for all technical aspects of the product, including instruments and systems throughout the product lifecycle.
Regulatory Compliance:
Ensure product development and V&V activities align with regulatory standards (e.g., FDA QSRs, ISO 13485, ISO 14971). Support documentation and submission efforts as required.
Design Control:
Participate in and support the design control process, including documentation, reviews, traceability, and compliance with quality management systems.
Sustaining Engineering:
Assist in post-market product support, including root cause analysis and engineering evaluations to address product issues or improvements.
Quality and Compliance Authority:
Exercise authority to hold any product or QA/RA documentation from shipment or further processing in the event of potential non-compliance. Escalate concerns to direct supervisor or higher management promptly.
Qualifications:
3+ years of recent experience as a Verification & Validation Engineer in a fast-growing medical device company, ideally focused on specialty medical practices.
Project Management Skills: Strong planning and organizational skills, with the ability to manage schedules and meet deadlines. Shows initiative and persistence in driving tasks to completion.
Technical Writing: Clear and accurate technical writing skills, with close attention to detail.
Standards-Based Testing: Experience performing testing in accordance with industry standards such as ISO or ASTM.
Communication & Teamwork: Strong communicator who works well with engineers, surgeons, clinicians, and sales/distribution teams.
Cross-Functional Knowledge: Solid understanding of how different areas of a medical device company work together - including engineering, manufacturing, R&D, product marketing, clinical, regulatory, and quality.
Test Fixture Design: Experience designing and building mechanical test fixtures using tools like mills, lathes, or 3D printers.
Senior Product Development Engineer
Project engineer job in San Leandro, CA
The Sr. Product Development Engineer designs and develops Class I & II medical devices for eye surgeries, such as vitrectomy probes. These devices have features down to 2 micrometers that need to be precisely manufactured and assembled. As a team member of the R&D Department, close collaboration with the Manufacturing Engineering, Quality and Production Teams is part of the daily routine. Responsibilities include improvement projects as well as end-to-end product developments from concept to manufacturing. Critical thinking is essential at all stages of the development process.
RESPONSIBILITIES:
Performs complex mechanical designs, engineering analyses and feasibility studies for new components or products
Works out the design requirements and determines optimum design choices, including via trade-off studies of various options.
Approaches troubleshooting by methodical, scientific means to identify root cause prior to implementing possible solutions through redesign
Thorough documentation of work performed, as required by the regulatory environment per 21 CFR 820.
Researches, understands, and presents information relating to Regulatory and Environmental Standard compliance requirements as it relates to product and processes.
Collaborate with Manufacturing in supplier selection, manufacturability, and the transition from R&D to manufacturing to ensure smooth and efficient design transfer.
Supports evaluation for viable Engineering Changes
Research new enabling technologies and manufacturing techniques and determine feasibility.
Responsible for project related functions including preparing, managing, and facilitating development of plans, schedules, tasks and resources from conception to volume manufacturing
Generate technical drawings of systems, components, and interfaces based on inputs provided by others.
Provides sustaining engineering support for existing products.
Work in a stage-gate product development process following principles of FDA design controls
Engage with cross-functional teams including Quality Assurance to ensure smooth project execution.
Generates patentable designs and proprietary manufacturing processes.
Competitive market analysis
REQUIRED SKILLS AND EXPERIENCE:
Proficient in SolidWorks, FEA, GD&T
Demonstrated ability to solve problems via scientific methodology and analysis (for example Theory of Knowledge)
Medical Device experience, FDA 21 CFR 820 & ISO 13485
Familiar with the manufacturing, assembly and bonding processes of consumable medical devices.
Experience with sterilization, biocompatibility requirements
Developing IQ/OQ/PQ, process validation documents
Risk Management per ISO 14971.
Requirements definition and traceability through verification and validation testing
Works and communicates effectively with people from all levels of the organization
Flexible and willing to perform other tasks as assigned
Travel - less than 10%, domestic & international
EDUCATION:
BS in Mechanical Engineering, Physics, or equivalent, 8+ years of experience
Advanced degree desirable
ADDITIONAL SKILLS AND EXPERIENCE DESIRED:
Methodical root cause analysis (DMAIC), detail-oriented
Mechanics of materials
Electronics concepts to control valves and pumps for liquid management systems
Micro-machining techniques
Familiar working with suppliers and vendors
Use of standard machine tools to fabricate simple tools and fixtures is a plus
Annual Compensation: $150,000 - $180,000 DOE (Depending on Experience)
Location: San Leandro, CA (Onsite, Full-time)
Company Website: ***************
Employment Type: Full-time
Medical Instrument Development Laboratories, Inc. (MIDLabs) is an equal opportunity employer. We are committed to fostering an inclusive, diverse, and respectful work environment and do not discriminate based on race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, or any other legally protected characteristic. Applicants from all backgrounds are encouraged to apply.
Product Design Engineer V
Project engineer job in Sunnyvale, CA
Job Title: Product Design Engineer V
Duration: 12 Months
The Product Design Engineering team is working on cutting edge technology and needs help from skilled engineers that will help bring ideas to reality. The main function of this Product Design Engineer is to explore and implement new designs, then to validate technical and product level functionality, use cases, and tech maturity. In parallel with de-risking efforts, you will be preparing production documentation including governing design files and bill of materials. You will work closely with Asia based JDM suppliers, guiding and managing them through the design and build phases. You will also work alongside a diverse and expert cross functional team.
Responsibilities:
7+ years of product design and development experience of handheld and/or wearable high-volume consumer electronics, including complex subsystems and/or full systems ownership.
Lead the mechanical design for a particular component, feature, or system while having end-to-end product development understanding
Contribute to mechanical solutions as part of a highly cross-functional team - Model, build, test, and refine prototypes and characterization test systems -
Work across the full product development cycle, from concept inception to shipping product, along with our JDM partners
Collaborate and manage work with Asia-based Supply Chain - Push state-of-the-art technologies and approaches to solving complex mechanical problems while working with cross functional technical teams
Experience with:
Designing and shipping products with Asia-based supply chains, including with JDM working model
Designing with softgoods materials
Designing highly cosmetic products and working with Industrial Design
Designing mechanisms
Designing for reliability, familiarity with reliability and compliance testing
Testing and analysis (FEA, Simulation, Design of Experiments, etc.)
Proficient in NX
Degrees: Master's degree in mechanical engineering, related engineering field
Application Engineer - Tulip
Project engineer job in Milpitas, CA
Immediate need for a talented Application Engineer - Tulip. This is a 06+ months contract opportunity with long-term potential and is located in Milpitas, CA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 25-89472
Pay Range: $65 - $70/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Work independently to specify, plan, design, develop, test and support software components assigned
Contribute to project schedule generation including scope of work, duration of tasks, and order of execution
Monitor work progress against schedule commitments, reports progress to leadership in a timely fashion, including when work will not be completed according to schedule milestones
Propose solutions to maintain schedule milestones including prioritizing efforts and monitor scope creep
Work with team to establish necessary requirements specifications and test plans for software product validations
Responsible for translating requirements into design and implementation of well-structured and documented software components
Implement new software component designs or enhancements to existing software products; participate in the implementation of more complex subsystems and systems
Troubleshoot/debug issues within existing automation systems and implement modifications to resolve these issues
Participate in technical design reviews and code inspections
Insure adherence to IDS development policies and procedures
Ensure compliance with regulatory requirements including 21 CFR part 11 requirements, quality standards, and conveys an expectation of high-quality software
Key Requirements and Technology Experience:
Key Skills; Tulip / MES Application Development
C#, JavaScript, and SQL Programming
Process Automation in Regulated (FDA/ISO) Environments
Require a BS degree in Computer Science, Process Engineering, Continuous Improvement, or a related Engineering discipline with software development experience
Excellent written and oral communication and interpersonal skills are essential
Minimum 3 years of relevant experience
Knowledge of software development in a process oriented/regulated environment and adhering to a quality management system
Experience with Agile software development
Knowledge of Automation/Process Control experience
Application development experience using Tulip
Experience in MES development
Experience working in an FDA/ISO-regulated environment
Experience with software languages including C#, JavaScript and SQL Server
Experience with Power BI
Software development with a focus on UX design
IT infrastructure/ hardware
Our client is a leading Medical technology Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.
Medical Device Quality Electrical Engineer II
Project engineer job in San Jose, CA
The Quality Electrical Engineer II develops and implements appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards. Work with problems of moderate scope where the analysis of the situation or data requires a review of identifiable factors. Exercise judgment to determine appropriate action. Communicate and implement quality objectives.
Specific Duties and Responsibilities
• Collaborate in the development and qualification activities for new and existing products*
•Perform PCB function verification to ensure all functions meet design specifications, validating critical parameters such as power and signal integrity margins
•Maintain and track critical hardware PCB issues, document findings, and ensure effective communication with relevant stakeholders
• Collaborate in the development of testing and inspection methodology and documentation for new and existing products*
• Collaborate on Quality Objective teams*
• Design and install QC process sampling systems, procedures, and statistical techniques*
• Design or specify inspection and testing mechanisms and equipment*
• Perform failure analyses and defect investigations *
• Analyze production limitations and standards *
• Recommend revision of specifications *
• Interface with other engineering departments within the company, customers, and suppliers on quality related issues*
• Collaborate in the development of standard operating procedures*
• Facilitate and perform internal audits*
• Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
• Perform other work-related duties as assigned
*Indicates an essential function of the role
Location and Salary:
• Location: Alameda, CA
• Salary: $95,000 to $127,000
• Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift.
Position Qualifications
Minimum education and experience:
• Associate's or Bachelor's degree in Engineering, a Life Science, or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or equivalent combination of education and experience.
Additional qualifications:
• Familiarity with QSR, ISO and other applicable regulations and laws required
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Experience with Electronic devices and or PCBAs
• Excellent verbal, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint
Working Conditions
• General office, laboratory, and cleanroom environments
• Potential exposure to blood-borne pathogens
• Requires some lifting and moving of up to 25 pounds
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
What We Offer
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
Senior Electrical Engineer
Project engineer job in Milpitas, CA
We're seeking a Senior Electrical Engineer to join our client's growing Supply Chain Engineering team in the Life Sciences sector. This is an onsite role requiring daily collaboration with cross-functional teams including Manufacturing, Quality, and R&D. The engineer will investigate non-conforming materials and part failures, working with prototype analog/digital circuits, schematic capture, and PCB layout. Responsibilities include defining electrical subsystem requirements and ensuring compliance with evolving global safety and regulatory standards.
In this role, the Electrical Engineer will work onsite daily, collaborating cross-functionally with teams such as Manufacturing, Quality, and R&D to investigate non-conforming materials and part failures. They'll engage in hands-on work with prototype analog/digital circuits, schematic capture, and PCB layout, while defining subsystem requirements and ensuring compliance with evolving global safety and regulatory standards. The engineer will drive improvements in PCB yield and scrap reduction, troubleshoot high-failure components with suppliers, and manage component end-of-life replacements, including redesigns for manufacturability. They'll lead and support technical projects using Six Sigma and FPx tools, contribute to supplier capacity planning, and participate in quality investigations and lifecycle design changes. The role also involves budget management, cross-functional coordination across global teams, and maintaining strong relationships with procurement, supplier quality, and operations partners to ensure continuity of supply and technical excellence
Required Skills & Experience
5+ years of hands-on electrical engineering experience in a medical device environment, particularly within a production setting
Familiarity with regulations including but not limited to ISO 13485, FDA and IPC standards
Experience in troubleshooting electronics, component debugging, and printed circuit board assembly (PCBA)
Ability to be onsite in Milpitas 5x week
Nice to Have Skills & Experience
Familiarity with laser optic devices
Experience working with international suppliers, ideally within efforts to move circuit boards to global markets
Proficiency in Six Sigma, Process Excellence, or LEAN methodologies
Compensation:
$70/hr to $80/hr.
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Project Engineering Manager
Project engineer job in Fairfield, CA
MSI Americas is a multinational with presence in 14 countries throughout America, trajectory in the Telecommunications & IT sector and the best work team, we believe in offering services and products that allow the humanized use of technology connecting it with society.
🔹Role: Project Engineering Manager
🔹Reports To: Head - Business and Commercial Operations
🔹Department: Project Engineering
🔹Work Location: Fairfield, California
🔹Job Type: Full-time
Industry Segment: IT / ITES / Power & Energy / Energy Utilities / Renewables
Objective:
The Project Engineering Manager is responsible for leading engineering projects, coordinating with cross-functional teams, and ensuring successful project delivery. This role requires a blend of technical expertise, leadership skills, and project management capabilities to manage resources, timelines, and project objectives effectively. In this role, you will provide pre-sales support, work with customers to define requirements and work with L&T internal team to create a detailed requirement plan for execution.
In post-sales, you will be working with the project manager and Project Engineers to deploy, install, and configure and commission projects as defined in the customer requirement document.
Key Responsibilities:
Project Planning and Execution:
• Develop detailed project plans, including scope, schedule, resources, and budgets.
• Define project goals and deliverables that align with business objectives.
• Oversee the engineering design and development process, ensuring adherence to quality standards.
Team Leadership and Coordination:
• Lead and mentor a team of engineers and technical professionals.
• Coordinate with internal teams (e.g., design, production, quality assurance) and external stakeholders (e.g., clients, suppliers).
• Facilitate regular project meetings and status updates to ensure alignment and address any issues.
Budget and Resource Management:
• Prepare and manage project budgets, ensuring cost-effective solutions.
• Allocate resources effectively and optimize the use of personnel and equipment.
• Monitor project expenditures and implement cost control measures.
Risk Management:
• Identify potential risks and develop mitigation strategies.
• Address technical challenges and resolve project issues promptly.
• Ensure compliance with safety regulations and industry standards.
Quality Assurance:
• Oversee the quality control processes to ensure deliverables meet the required standards.
• Implement best practices for engineering processes and project management.
Stakeholder Communication:
• Serve as the primary point of contact for project-related communications.
• Prepare and present progress reports, project documentation, and performance metrics to stakeholders.
• Manage client expectations and address any concerns or changes in project scope.
Basic Qualifications:
• Bachelor's degree in Engineering (Electrical, Civil, or related field).
• Master's degree or Professional Engineer (PE) license is a plus.
Certifications:
• Project Management Professional (PMP) or similar certification is preferred.
• Certifications related to engineering disciplines or project management methodologies are advantageous.
• Certifications in OSI Monarch or GE e-terra is a plus
Required Experience:
• Minimum of 5-7 years of experience in engineering, with at least 3 years in a project management or leadership role.
• Managed small team of Project Engineers and Delivery Managers.
• Proven track record of managing complex engineering projects successfully.
Skills:
• Strong project management skills with experience in using project management software (e.g., MS Project, Primavera).
• Excellent leadership and team management abilities.
• SCADA experience.
• EMS experience.
• Familiar with GE or OSI software or Control room applications.
• Strong analytical and problem-solving skills.
• Effective communication and interpersonal skills.
• Proficiency in relevant engineering tools and software.
• Strong technical writing skills.
Desired Experience, Skills and Knowledge:
• Experience with Electric Vehicle Chargers, Controllers, Battery Energy Storage Systems, Energy Efficiency, and/or Solar
• Experience in using Salesforce.
Behavioral Attributes:
• Strong analytical skills able to interface customers' desires and technical requirements.
• Good communication skills with external customers, partners, and suppliers
• Experienced in multi-cultural working environments.
• Team player with excellent team communication skills and knowledge sharing ability.
• Inclined to be a change agent with high energy and drive for innovation.
• Mentoring and coaching abilities
• Demonstrated ability to motivate & inspire others.
• Strong connections to the community and desire to help others.
Benefits:
• Competitive compensation
• Medical insuranc
• Life insurance
BIOPHARMACEUTICAL - SR C&Q ENGINEER
Project engineer job in Hayward, CA
Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services.
MMR Consulting has offices in Canada, USA, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the client's facilities in San Francisco Bay Area, California.
This role is for Bioprocess Sr. C&Q Engineer role to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor intermediate/junior engineers.
Responsibilities
Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, etc.
Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
Experience with C&Q of process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
Engage other departments, as required, for design reviews and decisions.
Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
Visit construction and installation sites following all site safety requirements.
Other duties as assigned by client, and/or MMR, based on workload and project requirements.
Qualifications
8-12+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
Excellent written and spoken English is required including the preparation of technical documents in English
Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required
Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset, but not required.
Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
Ability to lift 50 lbs.
Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline.
Ability to handle multiple projects and work in a fast-paced environment.
Strong multi-tasking skills
Salary range: 100,000$ -145,000$ based on experience.
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
Project Manager
Project engineer job in Oakland, CA
Job Title: Project Manager
Type: Full Time
Our client is looking for an experienced Project Manager to lead cross-functional initiatives from concept through completion. In this role, you'll manage multiple medium-to-large projects, align workstreams with organizational goals, drive schedules, resolve roadblocks, and ensure successful outcomes across stakeholders.
What You'll Be Doing
Lead and manage projects through the full lifecycle - from discovery and planning to execution and close.
Develop integrated project schedules, track progress, and identify critical paths.
Monitor project health and escalate risks or blockers to keep initiatives on track.
Assign ownership, set deadlines, and drive accountability across teams.
Identify potential risks and develop mitigation strategies.
Coordinate resources and timelines across internal teams and external partners.
Communicate project updates, impacts, and outcomes to cross-functional and executive stakeholders.
Foster collaboration across operations, technology, and vendor groups.
What We're Looking For
Bachelor's degree
7+ years of experience leading complex projects
Strong command of project management methodologies and tools
Skilled in communicating with leadership and diverse stakeholder groups
Ability to manage competing priorities in a fast-moving environment
PMP certification (or willingness to complete within 12 months)
Bonus: Experience in healthcare or highly regulated environments
Project Manager
Project engineer job in Foster City, CA
Job Title: Project Manager/ PMO Processes & Tools Senior Project Manager
Duration: 6+ months
Pay rate range: $95.00 - $102.00/hour on W2.
Job Description
The Program Management Office (PMO) at client supports some of the company's most complex, cross-functional decisions and programs. When needed, members of the PMO will roll up their sleeves and work hand in hand with engineering and operations to solve issues that arise.
We pride ourselves on our ability to take complexity and translate that into meaningful actions and high-quality, timely decisions. We have a strong track record of helping the organization execute more effectively across a number of different programs and initiatives. We do this through clear thinking, problem-solving, implementing improved operational measures, and influencing and coaching tactics.
The PMO Processes & Tools Senior Project Manager will take end-to-end responsibility for defining and rolling out new processes and tools, or making improvements to existing ones. This will go from working with stakeholders to define problem statements and requirements, all the way to training and supporting users during implementation.
Responsibilities:
Lead Implementation Projects: Manage the end-to-end project lifecycle for defining and deploying new PMO processes and tools, including requirements gathering, process definition and documentation, tool configuration, integration in the broader process and tool ecosystem, user training, and rollout.
Stakeholder Management: Act as the primary point of contact between PMO, IT, and business stakeholders to ensure project objectives are aligned and a shared understanding of requirements is maintained.
Process Improvement: Analyze existing program management workflows, identify bottlenecks, and drive the implementation of process and tools improvements to improve the scalability, efficiency and effectiveness of our processes..
System Administration & Support: Serve as a subject matter expert for our core PMO tools (e.g., Jira, Confluence, Structure, Rich Filters, etc…) as well as BI tools (e.g., Amazon QuickSight, Looker or similar), providing guidance, developing best practices, and creating user documentation.
Training & Adoption: Develop and deliver training materials to ensure the successful adoption of new tools and processes across the organization, driving user proficiency and engagement.
Planning, Reporting & Communication: Establish project plans, track progress against milestones, identify and manage issues and risks, and provide clear, concise status updates to leadership and stakeholders.
Qualifications
Bachelor's degree, preferably in technology-related field
8+ years of professional experience, with 5+ years of experience in technical project or program management, with a focus on systems and tools implementation.
Experience with both waterfall and agile product development lifecycles
Deep, hands-on expertise with enterprise-level project management software such as Jira, Confluence, Structure, or similar platforms, including leveraging data from such platforms to deliver insightful dashboards.
Proven track record of successfully leading complex, cross-functional projects from initiation to completion.
Excellent communication and interpersonal skills, with a demonstrated ability to influence stakeholders and drive consensus.
Strong analytical and problem-solving skills, with a talent for translating business needs into technical requirements.
Bonus Qualifications:
Experience working in a fast-paced hardware and software development environment (e.g., robotics, automotive, aerospace, or consumer electronics).
PMP, Agile certifications (CSM, CPO, SPC…), or other relevant project management certification.
Scaled Agile and/or hybrid agile framework experience with a proven ability to drive alignment and delivery across multiple teams and portfolios
Experience managing large-scale tool migrations or enterprise system integrations.
Familiarity with scripting or automation within PM tools (e.g., Jira automations, API integrations).
A passion for building efficient systems and a knack for making complex processes simple and intuitive for users.
Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:
Four options of medical Insurance
Dental and Vision Insurance
401k Contributions
Critical Illness Insurance
Voluntary Permanent Life Insurance
Accident Insurance
Other Employee Perks
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time
Staff AI/ML Engineer
Project engineer job in Sunnyvale, CA
Sunnyvale, CA (4 days/wk)
$200,000 - $225,000 Salary + Equity
We're partnering with an early-stage tech company developing next-generation radar-based AI systems for human activity recognition and vital signs monitoring. They're building products at the intersection of sensing, healthcare, and applied machine learning, and are looking for a hands-on AI/ML Engineer to help bring their models from concept to production.
Role Responsibilities:
Design, train, and deploy ML models for radar signal interpretation and human activity/vital signs inference.
Develop and maintain end-to-end ML pipelines - from data collection to validation and edge deployment.
Apply signal processing techniques to extract robust features from radar data.
Collaborate with hardware and embedded engineers to ensure seamless system integration.
Optimize and deploy models on C++-based embedded platforms for efficient on-device inference.
Requirements:
6-8+ years in applied AI/ML engineering (ideally within a startup or small team).
Strong experience with Python (PyTorch, TensorFlow, TensorFlow Lite, scikit-learn).
Proficient in C++ - especially for edge or embedded ML deployment.
Solid background in signal processing, ideally radar-based systems.
Strong problem-solving mindset and ability to work autonomously.
Experience in healthcare, human monitoring, or sensor fusion.
Understanding of cloud-to-edge ML deployment.
PhD preferred (especially with experimental design, FDA study setup, and model evaluation experience).
Think you're a great fit? Please email the following notes and an attatchment of your resume to *****************************
Current Location / Commute to Sunnyvale
Work Authorization Status (This client can
not
sponsor or transfer visas)
Your Tech Stack
Any projects with radar / digital signal processing / deploying models on the edge
Earliest availability for a 15-20 min call
Verification Validation Engineer, Medical Device
Project engineer job in San Jose, CA
*** This is not a software role***
The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons
Responsibilities
Design Verification & Validation:
Plan, execute, and document design verification and validation (V&V) activities to support product development and ensure compliance with internal and regulatory requirements.
Technical Support:
Provide engineering support for all technical aspects of the product, including instruments and systems throughout the product lifecycle.
Regulatory Compliance:
Ensure product development and V&V activities align with regulatory standards (e.g., FDA QSRs, ISO 13485, ISO 14971). Support documentation and submission efforts as required.
Design Control:
Participate in and support the design control process, including documentation, reviews, traceability, and compliance with quality management systems.
Sustaining Engineering:
Assist in post-market product support, including root cause analysis and engineering evaluations to address product issues or improvements.
Quality and Compliance Authority:
Exercise authority to hold any product or QA/RA documentation from shipment or further processing in the event of potential non-compliance. Escalate concerns to direct supervisor or higher management promptly.
Qualifications:
3+ years of recent experience as a Verification & Validation Engineer in a fast-growing medical device company, ideally focused on specialty medical practices.
Project Management Skills: Strong planning and organizational skills, with the ability to manage schedules and meet deadlines. Shows initiative and persistence in driving tasks to completion.
Technical Writing: Clear and accurate technical writing skills, with close attention to detail.
Standards-Based Testing: Experience performing testing in accordance with industry standards such as ISO or ASTM.
Communication & Teamwork: Strong communicator who works well with engineers, surgeons, clinicians, and sales/distribution teams.
Cross-Functional Knowledge: Solid understanding of how different areas of a medical device company work together - including engineering, manufacturing, R&D, product marketing, clinical, regulatory, and quality.
Test Fixture Design: Experience designing and building mechanical test fixtures using tools like mills, lathes, or 3D printers.
Medical Device Quality Electrical Engineer II
Project engineer job in San Francisco, CA
The Quality Electrical Engineer II develops and implements appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards. Work with problems of moderate scope where the analysis of the situation or data requires a review of identifiable factors. Exercise judgment to determine appropriate action. Communicate and implement quality objectives.
Specific Duties and Responsibilities
• Collaborate in the development and qualification activities for new and existing products*
•Perform PCB function verification to ensure all functions meet design specifications, validating critical parameters such as power and signal integrity margins
•Maintain and track critical hardware PCB issues, document findings, and ensure effective communication with relevant stakeholders
• Collaborate in the development of testing and inspection methodology and documentation for new and existing products*
• Collaborate on Quality Objective teams*
• Design and install QC process sampling systems, procedures, and statistical techniques*
• Design or specify inspection and testing mechanisms and equipment*
• Perform failure analyses and defect investigations *
• Analyze production limitations and standards *
• Recommend revision of specifications *
• Interface with other engineering departments within the company, customers, and suppliers on quality related issues*
• Collaborate in the development of standard operating procedures*
• Facilitate and perform internal audits*
• Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
• Perform other work-related duties as assigned
*Indicates an essential function of the role
Location and Salary:
• Location: Alameda, CA
• Salary: $95,000 to $127,000
• Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift.
Position Qualifications
Minimum education and experience:
• Associate's or Bachelor's degree in Engineering, a Life Science, or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or equivalent combination of education and experience.
Additional qualifications:
• Familiarity with QSR, ISO and other applicable regulations and laws required
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Experience with Electronic devices and or PCBAs
• Excellent verbal, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint
Working Conditions
• General office, laboratory, and cleanroom environments
• Potential exposure to blood-borne pathogens
• Requires some lifting and moving of up to 25 pounds
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
What We Offer
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
Patent Associate Engineering 20904
Project engineer job in Palo Alto, CA
Large GP Firm with Cravath level compensation. An elite industry leader in Life Sciences & Patent Law. Very active with IPRs at the PTAB. A top firm for emerging companies and venture capital in technology and life sciences. Exceptional programs for lateral integration and professional development.
REQUIREMENTS
Patent prosecution law firm experience, patent bar membership, and a background in one of the following fields: electrical engineering, mechanical engineering, chemical engineering, materials sciences, artificial intelligence (AI)/machine learning (ML), or related disciplines.
A demonstrable interest in the life sciences either from industry or educational experience is strongly preferred.
Advanced degrees and prior patent agent experience are preferred. We also are seeking candidates with strong verbal, written, and interpersonal skills as well as superior academic credentials.
CONFIDENTIALITY
At Vanguard-IP, we respect the confidentiality of every candidate who contacts us. Furthermore, we will always obtain expressed authorization before submitting your resume to any of our clients.
**Should you have an interest in exploring opportunities in another location, we have hundreds of openings in other markets. Please apply now and our team would be happy to review your information for this or other openings in your location of interest.
#J-18808-Ljbffr
BIOPHARMACEUTICAL - SR C&Q ENGINEER
Project engineer job in Sunnyvale, CA
Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services.
MMR Consulting has offices in Canada, USA, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the client's facilities in San Francisco Bay Area, California.
This role is for Bioprocess Sr. C&Q Engineer role to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor intermediate/junior engineers.
Responsibilities
Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, etc.
Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
Experience with C&Q of process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
Engage other departments, as required, for design reviews and decisions.
Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
Visit construction and installation sites following all site safety requirements.
Other duties as assigned by client, and/or MMR, based on workload and project requirements.
Qualifications
8-12+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
Excellent written and spoken English is required including the preparation of technical documents in English
Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required
Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset, but not required.
Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
Ability to lift 50 lbs.
Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline.
Ability to handle multiple projects and work in a fast-paced environment.
Strong multi-tasking skills
Salary range: 100,000$ -145,000$ based on experience.
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.