Careers

Full time positions offer medical, dental, vision and life insurance, profit sharing, retirement plan, paid sick leave, paid vacation and other ancillary compensations.

To apply for any of these positions listed below, send your resume and contact information:

Human Resources Department

hr_dept@biocare.net or fax to: 925-603-8075

Please find a list of positions (if available) below:

Job Purpose:
The Junior Mechanical Engineer supports the mechanical design and construction of Biocare’s hardware products. Duties include mechanical design, prototype assembly, documentation, production engineering, and sustaining engineering.

Department:: Engineering

Essential Duties and Responsibilities:
Develop and design new products and modify and improve existing products within budgetary constraints and customer requirements.
Identify and evaluate suppliers and/or other outside sources as needed to meet design objectives.
Requisition parts, supplies, services and tooling as needed.
Maintain design control and full documentation of all active engineering projects.
Provide technical assistance to supporting departments when appropriate.
Provide complete working drawings and manufacturing instructions when a project is released from Engineering to Production.
Test and evaluate designs and provide product specifications or test data as required.
Provide incoming acceptance criteria for parts, assemblies and/or tooling to the manufacturing department.
Provide technical support both internally and externally.

Competencies:
High level of proficiency with SolidWorks Ver. 15 or later required.
Working proficiency with Microsoft Office suite required.
Highly motivated with a good ability to take direction but able to independently develop mechanical solutions that meet the directed goal.
Detail-oriented.
Ability to design from scratch and modify existing designs to improve overall performance, manufacturability, field serviceability, and cost effectiveness.
Tolerant of a highly dynamic environment that may require frequent re-designs and re-optimization of work previously done.
Strong collaborative skills, both with other engineering disciplines and with scientific, regulatory, quality, and production teams.
Strong written, verbal, and presentation skills.

Experience, Education and Certifications:
Bachelor’s degree in mechanical engineering (BSME) required.
Basic machine shop experience a plus.
Familiarity with computational fluid dynamics a plus.
Familiarity with finite element modeling a plus.
Familiarity with heat flow modeling a plus.

Job Purpose:
Provide leadership and technical contributions to IVD development of new products and assays, including pharma partnerships. Support existing product offerings and contribute to continuous process improvements, within the existing Quality System.

Department:: R&D

Essential Duties and Responsibilities:
Manage the development of new products under Design Controls, including designing and performing Verification and Validation testing, drafting of Design Inputs and Design Outputs, and implementing effective processes for Design Transfer and QC testing.
Support the continued production of existing product offerings through continuous improvements in reagent formulations and/or manufacturing processes, sourcing and validation of new raw materials, troubleshooting, and complaint investigations, as needed.
Serve as a technical leader for development of Class II and Class III products for 510(k) and PMA submission, including analytical and clinical study designs, protocol drafting and report preparation.
Provide internal leadership for companion diagnostic projects with external partners, by establishing project goals and timelines and managing design and development of companion diagnostic kits.
Ensure compliance with QSR, ISO 13485, and other external guidelines for development activities.
Contribute effectively to risk management activities for new products, including risk analysis and mitigation.
Establish a collaborative environment between the R&D, Engineering, Manufacturing, QC, QA and Regulatory teams to support efficient, accurate and compliant development of products.
Maintain complete, timely, accurate and legible records.
Supervise and/or mentor staff as appropriate.

Competencies:
Broad knowledge of chemistry, biochemistry, molecular biology, and /or cancer biology.
Minimum 3 years of experience in IVD product development under Design Controls.
Familiarity with immunohistochemistry and/or in situ hybridization assays.
Cross-functional experiencing integrating Manufacturing, QC, QA and RA requirements in the development process.
Proficiency in Design Control and regulated product development, including FDA 21CFR 820 and ISO 13485 compliant systems.
Excellent analytical and problem solving skills.

Experience, Education and Certifications:
BS in applicable field; Ph.D. preferred.
Demonstrated previous experience and record of publications and presentations.

Job Purpose:
Provides Technical/Applications support to customers and employees on all product related issues via telephone, web and email communication. Technical Support Specialist will have general knowledge of Biocare reagents (IHC, Molecular, Detection) and Instrumentation (Small and large instrumentation, software).

All Technical Support Personnel are expected to travel into the field when Field Applications Specialists are unavailable. All Technical Support Personnel are expected to provide expert level technical support knowledge of Histology, IHC, and ISH to actively promote Biocare Medical products and services. Troubleshoot instrumentation and software situations, train customers, optimize reagent protocols, create & submit paperwork, provide follow-up support, perform presentations/workshops, and participate in technical/business reviews.

Department:: Marketing, Education and Technical Support

Essential Duties and Responsibilities:
Answer incoming instrument and reagent calls from the Tech Support phone line; Answer Technical Support emails.
Perform “phone fixes” for instrument issues for troubleshooting and training; enter all calls and emails in CRM.
Initiate Field Service Requests via CRM as needed.
Support for International Distributors (via phone, email or SKYPE).
Open and complete RAs and CCs including required investigation, and follow up with clients to complete “reply to customer”.
Perform Field Applications Specialists duties for local clients as needed.
Conduct workshops at “Histology Society” state meetings.
Answer Field Service Engineer (FSE) and Field Applications Specialists (FAS) field questions.
Present and follow optimized and standardized Biocare Medical approved protocols.
Ensure that all client-calls are directed via TS for initial triage followed by detailed analysis to determine if an FAS or FSE is required on-site.
Review Technical Bulletins.
Provide technical guidance as needed to all internal Biocare departments.
Answer all general department related questions.
Liaising with R&D/Engineering/software teams to ensure accurate technical information is dispersed amongst TS/Apps to communicate the same message.
Daily review of technical support cases in CRM to ensure that questions on your product specialty are addressed appropriately – follow up if and when necessary.
Provide training as part of Education Center Training Team to team members, Biocare Medical employees and clients as required.
Provide instrument SW files to Software Team as needed.

Competencies:
General Histology, IHC, ISH and FISH techniques.
Ability to work in a high-pressured deadline oriented environment.
Basic computer skills required. Math skills to include figures and amounts such as proportions, percentages, and titers. High level of verbal communication skills. Attention to detail and good organizational skills.
Demonstrates independent judgement in resolving problems and making recommendations.
Basic understanding of GMP and its application to the job.
Ability to drive and rent a car.

Experience, Education and Certifications:
Bachelor’s degree in science or HT or HTL or QIHC required. Extensive experience in the field of Histotechnology with IHC a must.
Requires a valid non-restricted driver license. Any changes in status must be reported to management immediately.