Careers

Summary of Primary Responsibilities: 

With some guidance from Senior Engineering Management, use sound engineering judgment to perform M.E. analysis of proposed conceptual designs using classical engineering hand calculations as well as CAD software. Thermal, stress, tolerance, data analysis and other mechanical engineering principals will be employed.

Position Description and Responsibilities: 

• Data and tolerance analysis to develop metrics to evaluate equipment and component improvements
• Dimension parts and drawing using GD&T to improve tolerance stacks and yields
• Support manufacturing equipment using both data and hands on observations
• Hands-on, data collection, technical testing to develop test methods
• Experiment and Process design and monitoring
• Fixture design and development to improve efficiency and repeatability
• Build planning and data analysis to ensure quality of component inventory
• SPC implementation and evaluation of value add
• NCR investigations
• WI revision and monitoring
• Power point summaries of project progress and document/data organization
• Continuous improvement of testing and measurement methods to increase accuracy and throughput 
• Write and execute technical protocols, IQ/OQ/PQ’s for manufacturing and injection molding processes
• Generate project timelines and reliably execute to timelines using the available resources
• Perform root cause analysis on manufacturing defects and field return product
• Perform design verification testing using engineering lab equipment such as push/pull tester, flow meter, sound meter, high speed video and metrology equipment.

Position Qualifications:

B.S. or M.S. Engineering CAD Software (Solidworks preferred)

PC Tools: MS Office Suite, Matlab

Statistical Analysis: JMP, Minitab, DOE, Gauge R&R

Minimum Education:

BS Engineering

Minimum Experience

7+ years

Summary of Primary Responsibilities: 

The FP&A Manager is a key, executive-facing role that will report directly to the VP of Finance, and support Intuity’s continued growth as a commercial-stage medical device company. This role will partner with business leaders across Sales Operations, Manufacturing and Product Development organizations to develop annual budgets and multi-year forecasts. This role will monitor results and provide insight of key business drivers. Success in this role will require cultivating partnerships across teams, understanding the business and sales channels, have strong communication skills, and strategic thinking skills to drive value to the business.

Position Description and Responsibilities: 

• Coordinate and collaborate with other departments within the organization, such as Sales Operations, Manufacturing and Product Development, to further understand business objectives.
• Manage and participate in the budget and forecasting process by assisting with the formulation and collection of key assumptions, preparing facility-level budgets, and analyzing results, including revenue by various distribution channels (tradition brick-and-mortar pharmacy, direct-to-consumer, online pharmacy), operating expenditures, capital expenditures and headcount needs.
• Work with management to leverage external data to understand, interpret and challenge revenue and expense projections for short- and long-term financial models.
• Maintain excel models that serve as the primary source of entity-level financial projections
• Collaborate with leaders to deliver monthly reporting dashboards of key financial and performance metrics.
• Maintain gross-to-net revenue pricing models.
• Perform budget versus actual analysis at the consolidated and departmental levels to identify and understand variances, assess risks and opportunities, generate insights and communicate results to senior management.
• Responsible for reviewing and approving purchase orders for compliance with budget and accounting rules.
• Assist with due diligence process for financing events.
• Additional ad hoc requests as needed.

Experience and Requirements:

• 6+ years of increasing responsibility in financial analyses and accounting related roles.
• Professional experience in a medical device, pharmaceutical, or biotechnology organization preferred.
• Ability to establish strong business relationships and interact cross-functionally at all levels.
• Must possess strong problem-solving skills. Ability to work effectively to identify issues, gather relevant data points and generate insights and solutions.
• Must be a strong communicator capable of explaining/presenting complex financial concepts and problems clearly and effectively to all constituents.
• Customer service oriented; able to understand business requirements while maintaining ownership for projects and results.
• Highly detail oriented with strong analytical skills; experienced in developing financial models, leading analysis, and explaining options and implications.
• Highly motivated self-starter capable of working under pressure and prioritizing workload to meet deadlines.
• Strong team player with ability to demonstrate executive presence.
• Process and systems improvement mindset for creating solutions to problems that work across boundaries beyond this role.
• Technical accounting proficiency preferred.
• Experience with QAD ERP system preferred.

Minimum Education:

• A Bachelor’s degree in finance or accounting required
• CPA, CFA and/or MBA preferred

Summary of Primary Responsibilities:

The Recruiter/HR Generalist to help lead and manage the Recruitment process within the Human Resources Department, ensuring smooth operations and talent to grow the company. The Recruiter / HR Generalist will work closely with the Sr. Director of HR and Scheduling Team and other team members to help staff according to company needs. The Recruiter will play a crucial role in finding and hiring top talent to support our company's growth and objectives. The ideal candidate will have a proven track record in full-cycle recruitment, ability to perform HR Administrative tasks as needed, process new hires and completion of the onboarding process, possess excellent communication and interpersonal skills, and thrive in a fast-paced environment.

The basic duties listed below are necessary to meet the minimum requirements of the position. Other duties may be assigned at the discretion of the Sr.HR Director or Senior Management.

Position Description and Responsibilities:

• Collaborates with Company hiring managers to identify and draft detailed and accurate job descriptions and hiring criteria.
• Generate new applicants, develop, and maintain applicant recruiting pipeline in a professional process, conduct initial interviews for open positions.
• Implement efficient and effective recruiting methods and coordinates with the Sr. Director of HR on strategies based on the position requirement.
• Complete job posting and advertisement processes.
• Screens applications and selects qualified candidates via phone, email and in person at the Company’s corporate Fremont Offices.
• Place recruitment ads as necessary in relevant hiring portals based on scheduling requests.
• Ensure applicants scheduled for follow-up interviews meet minimum qualifications of the position we are recruiting for.
• Maintain a detailed applicant log including source of recruitment, maintains all application files, ensure compliance with Equal Opportunity Employment, manages a step-by-step hiring process, conduct employment verifications, provide orientation, and perform other tasks related to the role.
• Maintain "new hire paperwork" and ensure copies are available for recruits and assist with other HR Admin tasks as needed.
• Be a liaison between candidates and departments regarding onboarding schedules.
• Meet expectations of a minimum of 8 hires a week or depending on needs at the time which will be determined and subject to change based off needs.
• Send out a retention summary every Friday with details regarding applicant flow.
• Assist with phone coverage as needed.
• Reply to emails and voicemails promptly, preferably no later than end of business day.
• Regular and punctual attendance is required!
• Maintain clean business attire, present yourself professionally to internal and external contacts.
• Other duties as needed.

 Position Qualifications:

• Proven work experience with a minimum of 3 years as a Recruiter in a fast-paced environment.
• Thorough knowledge of general Recruitment processes and procedures.
• Hands-on experience within the realms of the Recruitment role.
• Familiarity with full on Recruitment.
• Excellent verbal and written communication skills and demonstrate the ability to be customer service oriented, with the ability to interact with all levels of individuals in a courteous manner.
• Good problem-solving abilities and the ability to stay up to date with the latest technology and Recruiting systems.
• Ability to work independently while managing multiple projects and deadlines.

 Education and Experience:

• Recruiting: 3 years (Required)
• BA/BS is a plus
• Relevant experience in Medical Device or Pharmaceutical Biotechnology

Summary of Primary Responsibilities: 

Performs Operation of Industry standard automated assembly systems. Ensures quality of product. Employees in this class are expected to quickly grasp new ideas and techniques, exercise independent judgment in the field and have a solid understanding of quality expectations. Essential duties and responsibilities include the following; other duties may be assigned: (1) Performs routine work in all production areas with limited supervision (2) Ensures quality of product through the use of standard operating procedures, templates, training, supervision and good judgment. (3) Provides input for enhancing efficiencies and modifying/creating SOPs to ensure accuracy/quality or improve productivity. Must have a firm understanding of quality expectations and standards and be able to make independent judgment based on those standards. Will also assist other team members within a broad range of work centers in a manner that best promotes the success of the Production Group.

Position Description and Responsibilities: 

• Support day-to-day manufacturing activities including line set-up, completing electronic batch record documentation and meeting manufacturing goals
• Feeding raw material or parts to semi-automated and automated machines
• Carry out production, inspection, packaging and machine operation duties 
• Set up machinery and ensure all materials are readily available 
• Effectively monitor production equipment 
• Assist the shop technicians and materials clerk as necessary 
• Perform appropriate duties as assigned by management 
• Maintain a safe and clean work space 
• Adhere to all company policies and procedures.
• Follow established safety rules and regulations with a safety first approach

Position Qualifications: 

• Working knowledge of diverse high-speed Industry standard automated assembly systems in a manufacturing setting
• Skilled in the use of automation to assist in assembly processes 
• Ability to control machines and processes using either control mechanisms or direct physical activity to operate machines or processes.
• Ability to set up machines to start a production cycle
• Ability to control and adjust machine settings, clear jams safely with a proper sense of urgency.
• Strong verbal and written communication skills
• Understanding of production procedures
• Analytical skills
• Attention to detail
• Teamwork and communication skills
• Physical stamina and strength
• Able to lift a maximum of 50 pounds and stand for an eight-hour work shift

Minimum Education

• High school diploma

Minimum Experience:

• 4+ years in an assembly environment, preferably in the medical device industry

Position Summary:

The Senior Quality Engineer is responsible for providing quality engineering support for manufacturing POGO meter and cartridges on a day-to-day basis to ensure regulatory compliance.

Duties and Responsibilities:

• Work with Product Development, Operations and other departments to ensure regulatory compliance to POGO meter and cartridge manufacturing in accordance with 21CFR820 and ISO 13485.
• Develop and execute Quality Engineering activities to meet commercial milestones
• Support the analysis and evaluation of production capabilities, manufacturing problems, and the design and development of new products from the quality assurance perspective.
• Develop and implement product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, and FMEAs to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical-to-quality attributes
• Perform DHR Review of manufacturing performed while working on potential improvements to the overall documentation process.
• Participate in Risk Management efforts in accordance with ISO 14971 and Design Control efforts in line with ISO 13485, 21CFR 820 and IVDD.
• Train and mentor team members on best practices in quality engineering and regulatory compliance.
• Train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMEA, DOE, and statistical methods.
• Review and draft process validation plans and protocols, and conduct validation testing of new or updated products and equipment, fixtures or tools as necessary.
• Assist in the development, improvement, and management of product assurance systems such as incoming quality inspection, in-process quality assurance, statistical process control, calibration / preventative maintenance, CAPA, nonconforming materials, product lot release testing, and finished goods control. 
• Participate in internal and external audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications.

Required Skills:

• 7+ years of experience in a quality engineering role in the medical device industry with experience in complex systems strongly preferred. 
• Strong reading, writing and speaking competency in English
• Fluent in a wide variety of Quality tools such as Fishbone, 8D, 6S, 5 Why Analysis processes.
• Word processing, spreadsheet, Internet, e-mail, manufacturing, statistical and database software such as Minitab or JMP.
• Working knowledge of regulatory requirements such as QSR, ISO13485, and IVDD
• Strong collaboration, team building and development skills
• Strong written, verbal and interpersonal skills
• Prior experience working in emerging, start-up companies desired 

Minimum Education:

• B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience. 
• ASQ CQE (Certified Quality Engineer), CQA (Certified Quality Auditor) or other relevant certification is highly desirable.

Position Summary:

The National Account Manager is responsible for the execution of a Market Access strategy for gaining access with Payors. The National Account Director will establish managed care coverage and employer customer access to drive early adoption of company’s product. 

Position Description and Responsibilities: 

• Execute company Market Access strategy and deliver payer value proposition to maximize managed care access and new product entry/adoption.
• Partner with cross-functional teams to maximize business development opportunities and achieve overall company revenue goals.
• Develop and implement Market Access pull-through programs with field sales to optimize managed care coverage and deliver on the company’s growth objectives.  
• Maintain in-depth knowledge of current and evolving payer market landscape and diabetes disease space.
• Manage key payer relationships and negotiations to secure managed care coverage and positive payer policies that are consistent with the company’s strategy for revenue growth.
• Foster relationships with target employers to drive additional revenue opportunities.

Position Qualifications: 

• Extensive knowledge of pharmaceutical/medical device industry with emphasis in managed care.
• Must be able to communicate well with contacts at all levels.
• Strong interpersonal negotiating and analytical skills.
• Ability to think creatively and develop non-traditional solutions to complex business challenges.
• Demonstrated experience in executing successful market access payer contracting strategies and pull-through strategies.

Minimum Education

• BA/BS or equivalent combination of training and experience is required.

Minimum Experience:

• 10-15 years of related experience in managed care and sales required.
• Diabetes or blood glucose industry experience preferred.

Working Conditions:

• Must be willing to travel 50%+.  Primarily domestic travel, international travel possible.