Engineering Jobs in Canyon Crest, CA

This key role drives consistency across QA systems and processes for the Clinical QA team, identifying issues and risks, escalating in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality Management (OQM) to address day-to-day clinical trial operations activities focused on deviations, investigations, audit findings and CAPAs. This role operates across all the Clinical project teams and provides training with inspection readiness activities as required.

Essential Duties And Responsibilities:

• Responsible for designing and coordinating a comprehensive view and aligning standards on Quality systems across Clinical Quality Assurance.
• Assesses current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Systems and internal processes related to GCP QA activities
• Develops, tracks, and manages periodic management reports focused on track and trend data for key Clinical and QA metrics driving the quality health of the GCP activities.
• Reviews and approves Deviations, and Corrective and Preventive Actions (CAPAs)
• Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance
• Maintains knowledge of current Health Authority regulations and standards and informs Clinical Development stakeholders of potential impact on the organization
• Represents CQA in internal presentations on quality issues, initiatives, and projects
• Identifies issues and risks and proposes options and solutions, escalating risks in a timely manner.
• Participates in identifying and implementing process and system improvements

Supervisory Responsibilities:

None

Education/Experience/Knowledge & Skills:

• Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 11 years of relevant experience; or,
• Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of relevant experience; or,
• PhD degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 5 years of relevant experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Minimum of 10 years relevant experience in pharmaceutical and biotech industries.
• Experience in Good Clinical Practices highly desired
• Demonstrated experience in Quality Systems including critical analysis of impact and continuous improvement processes
• Strong understanding of Quality Risk Management
• Experience using standard MS Office

Knowledge/Skills:

• Understanding of the drug development process, particularly related to QA oversight of clinical trials
• Experience in assisting in the development of business strategies, metrics, and continuous improvements
• Working knowledge of Health Authority rules and regulations
• Proven ability to manage Quality Systems, assuring completeness and acceptability as defined for GCP.
• Ability to apply Quality Risk Management in a variety of situations across Quality Systems
• Ability to influence others as part of a collaborative team and negotiate effective solutions
• Strong interpersonal and social skills
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
• Detail-oriented in execution of tasks and processes
• Implements technical solutions within quality requirements to complex problems.
• Excellent verbal and written communication skills
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Provides insight and analysis of situations or data requires a review of a variety of factors.

Working Conditions:

• Environment: primarily working in laboratories or in office
• Infrequent travel may be required.

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $153,500 - $217,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Enterprise Account Executive – Fiddler AI

About the Company-

Fiddler is a fast-growing AI company focused on helping organizations build trust in artificial intelligence. As AI technologies—particularly Generative AI and autonomous agents—continue to evolve, businesses face increasing challenges around transparency, reliability, and governance.

Fiddler’s platform helps organizations monitor, evaluate, secure, and improve their AI systems in production. By providing deep visibility into how AI models behave, the platform enables engineering, data science, and business teams to understand the “what, why, and how” behind AI outcomes, allowing them to deploy AI solutions responsibly and at scale.

The company partners with AI-first organizations to establish long-term frameworks for responsible AI practices—ultimately helping build trust with their users and stakeholders.

Leadership

The company is backed by leading venture capital firms including Insight Partners, Lightspeed Venture Partners, and Lux Capital.

Fiddler has also been widely recognised for its innovation in AI Observability, including:

• Andreessen Horowitz (a16z) Data50 – 2022
• CB Insights AI 100 – 2021
• World Economic Forum Technology Pioneer – 2020
• Forbes AI 50 – 2020
• Gartner Cool Vendor in Enterprise AI Governance – 2019

The Opportunity-

Fiddler, is looking to hire an Enterprise Account Executive to help drive the company’s continued growth within enterprise markets.

This role focuses on developing strategic relationships with enterprise customers, identifying complex AI and machine learning challenges, and positioning Fiddler’s platform as a trusted solution. The successful candidate will be responsible for translating technical product capabilities into clear business value for senior stakeholders.

What You’ll Be Responsible For-

• Driving new revenue by prospecting, developing relationships, and closing enterprise deals with key decision-makers.
• Building awareness of Fiddler’s platform within target accounts and territories, identifying strategic opportunities for growth.
• Managing complex enterprise sales cycles involving multiple stakeholders, procurement processes, and budgets.
• Understanding customer challenges related to AI models and demonstrating how the Fiddler platform addresses those needs.
• Articulating clear business value propositions and differentiating Fiddler from competing solutions.
• Developing and executing go-to-market strategies to generate pipeline and accelerate demand.
• Consistently achieving or exceeding pipeline, activity, and revenue targets.
• Operating independently with strong ownership and accountability.
• Collaborating with internal teams to support broader company growth.
• Traveling as required (approximately 10–25%).

What We are Looking For-

• 5+ years of enterprise or outside sales experience
• Experience selling within Data, Big Data, Machine Learning, or AI environments
• Proven ability to sell technical solutions to technical audiences, including developers and data scientists
• Strong understanding of Machine Learning or Artificial Intelligence concepts
• Experience with cloud and enterprise technology environments
• Knowledge of MLOps and AI model governance (desirable)
• Experience targeting financial services organizations is beneficial

Staff Design Quality Engineer – Class III Implantable Medical Device

San Francisco Bay Area | Full-Time | Hybrid

A fast-growing medical device company developing next generation implantable technology is expanding its engineering team and hiring a Staff Design Quality Engineer to support the development of a highly innovative Class III medical device platform.

This is a highly technical, hands-on role embedded directly with R&D, focused on ensuring quality is built into product development from early feasibility through clinical and commercial stages.

You will play a key role in helping bring a breakthrough therapy to market while working alongside experienced engineers and cross-functional leaders in a collaborative development environment.

Responsibilities

• Partner closely with R&D and systems engineering teams to integrate design quality into product development
• Lead and support design control activities throughout the product lifecycle
• Drive risk management efforts (ISO 14971) including hazard analysis, FMEAs, and risk mitigation strategies
• Support verification and validation planning and execution
• Ensure compliance with FDA design control requirements and global quality standards
• Participate in cross-functional design reviews and technical decision making
• Help translate regulatory and quality requirements into practical engineering processes

Qualifications

• BS or MS in Engineering (Biomedical, Mechanical, Electrical, or related)
• 7+ years of experience in medical device product development or design quality
• Strong experience with design controls and risk management
• Experience supporting Class II or Class III medical devices
• Ability to collaborate closely with R&D in early-stage product development
• Experience supporting IDE, PMA, or complex regulatory pathways is highly valued

What Makes This Opportunity Unique

• Work on cutting-edge implantable technology
• Join a highly technical engineering-driven team
• Be involved early in the development lifecycle
• Significant opportunity for technical ownership and influence
• Competitive compensation, bonus, and equity package

If you are interested in learning more, feel free to reach out directly.

Job Title: Bay Area Sales Leader

Department: Sales / Alliances

Location: San Francisco Bay Area, CA (Hybrid)

Reports To: Chief of Alliance and Head of HiTech Business

Experience: 10–15 years

Position Summary

The Bay Area Sales Leader is responsible for regional revenue growth, new logo acquisition, and strategic account expansion across client full portfolio. This role blends enterprise hunting, consultative selling, and alliance-driven go‑to‑market execution. Success requires a leader who thrives in high‑growth environments, operates with autonomy, and brings a strong network within the Bay Area technology and cloud ecosystem.

Key Responsibilities

Revenue Growth & Territory Leadership

• Own regional revenue targets across Data & AI, Cybersecurity, Cloud Governance, Automation, and Digital Resilience.
• Build and manage a high-quality pipeline across enterprise and high-growth technology accounts.
• Lead the full sales lifecycle: prospecting, qualification, solution shaping, proposal development, negotiation, and closure.

Strategic Partnerships & Ecosystem Development

• Collaborate with the Chief of Alliance and HiTech Business to execute joint GTM strategies with hyperscalers (AWS, Azure, Google Cloud), ISVs, and technology partners.
• Strengthen clients presence in the Bay Area innovation ecosystem through partner engagement and co-selling motions.

Executive Relationship Building

• Build trusted relationships with CIOs, CTOs, CDOs, CISOs, and senior business leaders.
• Conduct executive briefings, workshops, and strategic discussions to shape client transformation roadmaps.

Market Engagement & Thought Leadership

• Represent client at regional AI, cloud, cybersecurity, and innovation events.
• Serve as a visible ambassador for client in the Bay Area technology community.

Cross-Functional Collaboration

• Work closely with solution architects, delivery leaders, and alliance managers to ensure successful execution and referenceable outcomes.
• Maintain strong pipeline discipline, forecasting accuracy, and executive-level communication.

Required Qualifications

• 10–15 years of experience in enterprise technology or services sales, with at least 8 years in direct sales or regional leadership.
• Proven track record of hunting and closing multimillion‑dollar enterprise deals.
• Experience selling in at least two of the following domains:
• Data & AI / analytics
• Cybersecurity
• Cloud governance, FinOps, or SecOps
• Intelligent automation
• Business continuity or digital resilience
• Strong understanding of enterprise transformation drivers including AI adoption, data modernization, automation, and security/compliance.
• Demonstrated ability to engage C‑suite executives and lead complex, consultative sales cycles.
• Bachelor’s or Master’s degree in Engineering, Business, Computer Science, or related field (MBA preferred).

Preferred Qualifications

• Established network within the Bay Area technology, AI, cloud, and innovation ecosystem.
• Experience building new territories or verticals in high-growth or entrepreneurial environments.
• Background working with hyperscalers (AWS, Azure, Google Cloud) and ISV partner ecosystems.
• Familiarity with venture-backed or innovation-driven enterprise environments.

Key Skills and Competencies

• Entrepreneurial mindset with strong ownership and accountability.
• Excellent communication, negotiation, and executive presentation skills.
• Strategic thinking with the ability to translate client needs into compelling solution roadmaps.
• Collaborative leadership style with the ability to influence cross-functional and partner teams.
• High energy, resilience, and adaptability in fast-paced environments.

Compensation and Benefits

• Competitive base salary with a high-performance variable incentive plan.
• Potential equity or long-term incentive opportunities tied to regional growth impact.
• Comprehensive benefits package including health coverage, retirement plans, and flexible PTO.
• Clear career progression pathways into broader regional or national sales leadership roles.

CoFlo Medical’s precision microfluidic technology delivers advanced biologic medicines at ultra-high concentrations by increasing injectability 100-fold. Our aim is to reduce the treatment burden for patients living with chronic diseases like cancer and autoimmune disorders by building platform products that enable at-home treatment. We are a high-energy venture-backed MIT spinout based in SF.

We’re looking for a Senior NPI Manufacturing Engineer to help accelerate our device production scale-up to commercial levels. In this role, you’ll own development of internal assembly and manufacturing processes in parallel with coordinating external vendors and manufacturers for scale-up. We are seeking engineers who thrive in fast-paced environments, take initiative, and are motivated by high-impact problems.

What You’ll Do

• Develop and optimize high-throughput production and assembly
• Design transfer from prototype –> pilot –> commercial
• Identify and overcome high-level process bottlenecks and risks
• Design, develop, prototype, and test devices, components, and assembly tooling
• Communicate, coordinate, and manage external vendors and suppliers

Qualifications

• BS or higher in related field
• 4+ years of experience in manufacturing engineering or process development
• Direct experience with high-volume plastic injection molding, single-use products, or medical devices
• Demonstrated mastery of DFM and DFA in addition to design, prototyping, and testing
• Desire to work in a fast-paced and high-agency environment

About Us

We’re ClosedWon Talent, a sales & go-to-market recruiting agency that specializes in working with fast-growing startups. If you're exploring your next move, we might have just the opportunity for you...including this one!

About The Company

We're helping a Seed-stage developer productivity startup hire their first two Founding Account Executives in San Francisco.

They’re building a platform for engineering leaders that goes beyond dashboards and vanity metrics. It analyzes real workflow data across the development stack and surfaces clear, actionable guidance on how teams can ship faster, reduce friction, and improve outcomes. This is sold as expertise and insight, not just another tool.

The Role

• Title: Founding Account Executive
• Report to: Founder
• Location: Hybrid in SF
• Comp: $100K–$150K salary, $200-300k OTE, plus equity

You’ll own full-cycle new business:

• Generate your own pipeline
• Work inbound leads
• Run discovery with engineering leaders
• Close mid-market and enterprise deals
• Help define how sales gets done

ACV ranges:

• $15K–$40K typical mid-market
• $50K+ enterprise entry point (with expansion upside later)

You’ll get a mix of faster-moving cycles and more strategic, multi-stakeholder deals.

Who They’re Looking For

Must-haves:

• Proven ability to generate pipeline in a scrappy environment
• Comfortable selling to technical buyers, especially engineering leaders
• Operates well with low process and high ambiguity
• High ownership mentality. Willing to do the unglamorous work

Nice-to-haves:

• Experience selling into engineering orgs or dev-adjacent tools
• Some technical or analytical exposure
• Evidence of fast progression or internal promotion
• Creative GTM experience: events, conferences, network selling, scrappy outbound motions

Aeonsemi is a pre-IPO chip design company at the forefront of high-speed data communication for Physical AI. Backed by tier-one venture firms and in rapid revenue growth, we design customer-proven synchronous Ethernet networking and timing solutions that address the critical needs of secure data connectivity, robust timing synchronization, and efficient energy delivery — from AI edge nodes, autonomous systems to hyperscale data centers.

Analog/mixed-signal Design Engineer

Responsibilities

You will be working with a team of designers to design high performance RF/Analog/mixed-signal circuits for high-speed wireline transceiver products using advanced CMOS technologies.

· Block level architecture design

· Schematic design, simulation, behavioral modeling, validation plan

· Supervise layout engineer and hands-on layout of critical paths when needed

· Lab characterization

Qualifications

· MS or Ph.D in electrical engineering with minimum 2 years of experience

· Knowledge of analog fundamentals: biasing circuits, clock generation and/or data converters

· Proficient in Cadence design environment

· Good communication skills

Additional Helpful Qualifications

· Proficient in Python or other programming language

. Basic proficiency with signal processing

. Interest in developing full-stack skills spanning mixed-signal design, simulation and modeling, and production test flows (software/firmware debug)

We offer

· Great team work environment with excellent career growth opportunities

· Competitive salary, attractive stock option

· Competitive benefit package with health care, dental, 401k etc.

Responsibilities:

• Ensure all design control activities for new and updated products meet company procedures and global regulatory requirements.
• Lead risk management activities, including hazard analysis, FMEAs, and risk documentation.
• Support sterilization and biocompatibility assessments.
• Own and maintain design control documentation.
• Partner with R&D, Regulatory, Manufacturing, and Project Management to ensure quality is built into every stage of product development.
• Maintain accurate test, validation, and risk records and report progress to leadership.
• Support regulatory submissions (e.g., 510(k), CE Mark).
• Lead root cause investigations and corrective actions related to design issues.
• Support complaint investigations, nonconformances, and CAPAs after product launch.
• Conduct DHF audits to ensure phase completion requirements are met.
• Review and approve engineering documents and test reports.
• Identify opportunities to improve product quality, reduce cost, and increase efficiency.

Requirements

• Bachelor’s degree in Engineering or related field.
• 10+ years of quality engineering experience in medical devices, including new product launches.
• Experience with sterilization and biocompatability
• Strong knowledge of design controls, risk management, and medical device regulations (FDA, ISO, IEC).
• Experience with verification & validation (V&V) and FMEAs.
• Strong problem-solving and statistical analysis skills (e.g., Minitab, JMP).
• Detail-oriented with strong documentation skills.
• Quality certifications (CQE, CSQE, Six Sigma) are a plus.

Role Overview

The AVP – Sales (CMT) is a strategic, quota-carrying leadership role responsible for driving revenue growth across targeted Communications, Media, Devices, and Semiconductor accounts in the San Francisco Bay Area.

This role will spearhead business development initiatives, build executive-level relationships (CxO, SVP, VP), and lead large transformation and engineering services deals within the Devices & Semiconductor vertical. The AVP will own the end-to-end sales cycle—from opportunity creation through contract execution—while collaborating with cross-functional teams including Inside Sales, Pre-Sales, Marketing, and Delivery.

The organization is a leading global digital engineering and technology services company delivering Product Engineering, ER&D, Cloud, Data, and AI-led transformation solutions to enterprise clients.

What You Will Be Provided

• Dedicated Inside Sales team for targeted outbound prospecting
• Industry-aligned Pre-Sales and Solutioning support
• Marketing support for account-based campaigns and executive outreach
• Established lead channels and partner ecosystem
• Access to differentiated offerings, industry use cases, client references, and domain SMEs to support deal pursuit and closures

Key Responsibilities

• Own and achieve monthly, quarterly, and annual revenue targets for the CMT vertical
• Develop and execute strategic account plans for Devices & Semiconductor accounts
• Build and nurture executive relationships across engineering, product, IT, and business leadership
• Drive large, complex deal pursuits including outsourcing, ER&D, digital engineering, silicon lifecycle management, and transformation programs
• Lead the complete sales lifecycle: prospecting, qualification, solution positioning, RFI/RFP responses, workshops, negotiations, and contract closure
• Build and maintain a strong sales pipeline aligned to revenue and margin objectives
• Collaborate closely with Pre-Sales and Practice teams to craft differentiated value propositions
• Ensure seamless transition to delivery and maintain executive oversight to drive long-term account growth
• Represent the organization in industry forums, executive meetings, and customer strategy discussions

What You Will Bring

• 15+ years of enterprise sales experience in Communications, Media, Devices, or Semiconductor industries
• Proven track record of closing large, multi-million-dollar deals in engineering services, digital transformation, or outsourcing
• Strong relationships within the Bay Area semiconductor and devices ecosystem
• Deep understanding of ER&D, product engineering, silicon lifecycle, embedded systems, semiconductor design, and platform engineering
• Ability to structure complex commercial models and large outsourcing engagements
• Strong consultative selling, account mining, and new logo acquisition capabilities
• Executive presence with excellent communication and presentation skills
• High ownership mindset with the ability to operate in a hunter-led, growth-focused role

Passion for emerging technologies including AI/ML, Cloud, Edge, IoT, Silicon engineering, and next-generation device innovation.

• Shape enterprise-wide QA/QC/QE strategy in a high-visibility leadership role
• Lead inspection readiness and partner directly with FDA/EMA
• Build and scale a high-performing Quality organization
• Influence antibody development, biologics manufacturing, and tech transfer
• Competitive salary, strong benefits, and onsite leadership visibility
  
  

• Driving Quality strategy, systems, and culture
• Leading QA/QC/QE teams and quality operations
• Managing audits, compliance, and regulatory interactions
• Overseeing QMS, CAPA, deviations, document control
• Supporting CMC, manufacturing, and client-facing quality needs
  
  

• 15+ years QA in pharma/biopharma; 5+ years leadership
• Extensive GxP and global regulatory expertise
• CDMO or biologics background preferred
• Strong communicator and cross-functional partner