careers

Current Opportunities


 

Microchips Biotech offers competitive salaries and benefit packages.  Please send your resume to Human Resources at careers@mchips.com.

 


 

Director, Quality

Overview of Position: The Director of Quality will be a hands-on leader developing and overseeing the implementation of the quality management system in compliance with FDA 21 CFR 820, 210/211 and EU AIMDD regulations and ISO 13485 standard. He/she will provide leadership and expertise to support products from preclinical development through commercialization. This key individual will work with the R&D team to apply risk-based decisions to ensure compliance to design controls and establish key areas for QA oversight for new products and processes, product testing and disposition, quality investigations, cGMP compliance and in matters involving aseptic manufacturing and laboratory operations. Responsible for managing the risk management process, change control, non-conforming material, deviations, OOS investigations and CAPA systems. This professional is expected to possess strong technical and interpersonal skills, lead by example and be able to work effectively in a high energy environment.

Primary responsibilities include but are not limited to the following:

  • Develop, establish and maintain phase appropriate quality systems, policies, procedures and controls ensuring that the quality of preclinical and investigational products conform to applicable regulatory requirements and company standards for drug delivery combination products.
  • Provide guidance to product development core teams and external partners to ensure development activities are performed in a phase appropriate manner, compliant with company and regulatory expectations
  • Works with the R&D team to ensure compliance to design controls and establish key areas for Quality oversight for new products and processes
  • Lead risk management activities
  • Manage and communicate quality data from multiple sources to assist in the risk management and risk-based decision processes
  • Develop and maintain quality plans
  • Manage the review and approval, as required, documents that support design control including but not limited to drawings, material specifications, travelers, batch records and technical protocols and reports
  • Responsible for managing the following systems: non-conforming material, deviations, OOS, investigations and CAPA
  • Manage documentation control and record-keeping systems for engineering documents and company procedures
  • Responsible for disposition of products
  • Manage the review and approval of executed history records and all associated documentation
  • Qualify and routinely monitor supplier performance and institute Quality Agreements as required
  • Plan and manage audit programs (internal and external) using risk based assessments, reporting findings/compliance metrics and implementing appropriate risk escalation and mitigation strategies
  • Assist with preparing for regulatory meetings and submissions

Requirements:

  • MS/BS degree, preferably in mechanical engineering
  • 10-15 years of experience in Quality, with strong knowledge and broad experience in both quality assurance and quality control activities. Combination products and/ or delivery system experience preferred
  • Subject matter expertise related to cGMP compliance and in matters involving design control, pharmaceutical development/facilities, aseptic manufacturing and laboratory operations preferred
  • Experience working in early stage quality assurance setting with a strong understanding of the drug development and registration process preferred. Strong knowledge of and broad experience in both Quality Assurance related to aseptic processing and Quality Control related activities
  • Demonstrated knowledge of the US and International standards governing the development, manufacture and study of combination products and/ or delivery systems; sterile product experience desired
  • Knowledge of Good Manufacturing Practices, Quality System Regulations and ISO 13485 standards is essential. Must have proven track record with the implementation and management of quality systems within a start-up organization
  • Knowledge of software quality assurance is required
  • Knowledge/experience required: risk management (ISO 14971), product reliability and safety assessments, design/process/use FMEcA, tolerance studies, design of experiments, gauge R&R, and statistical process control
  • Knowledge of basic statistical and engineering principals is essential
  • Must have experience with FDA inspections and ISO certification/surveillance audits
  • Experience with ERP systems, automated data collection systems, and product data management systems is a plus
  • Excellent written and verbal communications skills are critical
  • Project management skills a plus
  • Strong organizational skills.
  • Able to work in a team environment, manage multiple priorities in a dynamic small start-up environment
  • Solid experience supporting integrated products containing sophisticated mechanical, electrical, software and formulation components from preclinical development through commercialization desirable
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Senior Electrical Engineer

Overview of Position: We are seeking an experienced R&D electrical engineer with significant experience to develop our implant (active electronic device) and external components of our drug delivery implant and system.

Responsibilities Include:

  • Conduct electrical engineering analyses and design of wireless implants and remote programmers that interface with both the implant and personal computers
  • Create multi-layer circuit layouts for all electronic systems (implants and external devices)
  • Effectively and thoroughly incorporate required regulatory medical device requirements (FDA, EN, ISO, IEC)
  • Conduct technical design reviews
  • Contribute to the development of specifications for electronics
  • Lead the development and interface with consultants as required for the radio frequency circuit
  • Assist in the definition of the user interface for the external devices
  • Work closely with other hardware engineers and firmware engineers
  • Lead the prototyping and assist with testing efforts
  • Identify and work with appropriate prototype suppliers and external test facilities
  • Interface with the project manager, and a multi-disciplinary team including device engineers (MEMS, electronics, firmware, mechanical), test engineers, process development engineers, and formulation scientists, and provide schedule updates

Requirements:

  • 8 plus years industry experience in a medical device research and/or development environment
  • Thorough understanding of engineering practices, product safety, risk assessment and root cause analysis
  • Experience developing  embedded systems
  • Commercial experience with the design of wireless medical devices (active electronic implants and programmers)
  • Knowledge of Good Manufacturing Practices (GMP), Quality System regulation (QSR) and design controls
  • Experience with micro power, efficient and miniature circuit design
  • Experience with Bluetooth, NFC and USB protocols
  • Experience with electrical regulatory testing of medical devices, including IEC 60601, ISO 14708-1
  • Proficiency with electronic circuit layout software (Altium)
  • Able to lead efforts of self and other engineers
  • Strong written, verbal and presentation skills
  • Bachelor of Science degree in electrical engineering
  • Master of Science a plus
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Senior Software Quality Assurance Engineer

Overview of Position: Assist with developing and testing the software that is part of our drug delivery system.

Responsibilities Include:

  • Interface with software and systems engineers
  • Assist the development team in creating design control documents such as the software requirements specification and the software design specification
  • Develop software test methods and create software test plans for new or updated software projects to determine if the software will perform accurately and reliably according to documented requirements as well as established standards under both normal and abnormal conditions
  • Test the software system, including the use of automated test suite
  • Augment test framework by generating automated scripts as required
  • Create documentation consistent with regulatory requirements
  • Review code and conduct verification and validation tests
  • Recommend design improvements or corrections to engineers throughout the development process
  • Lead risk management meetings
  • Support manufacturing by verifying fixture software or any software used in production
  • Communicate status to the engineering team, management and partners

Requirements:

  • Bachelor of Science degree (in computer science, engineering, or related field)
  • 5 plus years medical device industry experience in a research and/or development environment as a software quality assurance engineer
  • Experience in quality systems and quality assurance methodology
  • Experience in writing test plans, protocols, and generating automated test scripts to perform software verification and validation
  • Experience with issues tracking software tools
  • Experience with scripting language such as Perl
  • Knowledge of FDA software development process, requirements and verification and validation
  • Knowledge of FDA cGMP
  • Knowledge of ISO 13485 and ISO 62304
  • Strong interpersonal skills, and documentation and writing skills
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Supply Chain Manager

Overview of Position: The Manager, Supply Chain will be a hands-on leader providing a systemic approach to supplier management and continuous improvement by developing a supplier management strategy, sharing the vision with suppliers, educating suppliers and coordinating improvement efforts concerning component and sub-assembly procurement. This professional is expected to be a high-energy individual with strong technical and interpersonal skills.

Primary responsibilities include but are not limited to the following:

  • Formulate and implement practices for building long-term supplier relationships which are consistent with company and regulatory requirements
  • Work closely with the R&D and Purchasing groups to build supplier partnerships.  Lead the effort to develop a team, develop an action plan, develop specifications and standards, prioritize product attributes determine process control and capability, measure performance, audit performance and improve continuously
  • Oversee the negotiation, development and maintenance of supplier agreements and leads critical negotiations
  • Manage supplier relationships to drive supplier performance, contract effectiveness, collaboration and integration to deliver results with the objective of reducing costs and eliminating inefficiencies
  • Work with Quality supporting the supplier management program to routinely monitor supplier performance relating to cost, quality and on-time delivery
  • Support supplier audits in conjunction with Quality Engineering.  Develop and maintain the supplier audit schedule and assure compliance with internal operating procedures.
  • Continuously evaluate and improve business practices by developing and instituting key performance indicators. Develops and revises process documentation, streamline opportunities and eliminate non-value added activities assuring compliance with regulatory requirements.
  • Build and maintain relationships with internal customers to ensure continuous improvement and that service level commitments are met
  • Participate in financial forecasting and budget development
  • Manage risk, timelines and works to ensure overall project transparency 

Requirements:

  • Bachelor degree in engineering discipline; masters preferred
  • 8 years + experience in leading supplier management programs or equivalent
  • Experience developing & leading robust supplier processes at a medical device start-up
  • Experience with both electrical (integrated circuits, batteries, pcb assemblies, workmanship standards) and mechanical (precision machining, brazing) components
  • MEMs experience desirable
  • Working knowledge of ISO 13485
  • Provide leadership for critical supplier relationship management challenges
  • Self-motivation and problem solving skills are extremely important in this position
  • Must be able to identify and deliver on high value sourcing opportunities, appreciate complexity of change and be able to align closely with R&D and Quality to deliver robust sourcing solutions
  • Well-developed organizational and inter-personal skills.  A self-starting and self-motivating individual with a positive attitude and influence on the organization.
  • Excellent communication skills, strong organizational skills and a tremendous sense of getting things done
  • Proficient with MS Office suite of products; Word, Excel, PowerPoint and Project
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