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Our mission is to promote the growth and quality of the bioscience industry in Oregon. We continually seek ways to support our membership community in achieving their full scientific, economic and social potential.
OBA is a non-profit association with membership open to any company, organization or individual with an interest in biotechnology, medical devices, or the life sciences.
Posted June 27th, 2008
We are Micro Systems Engineering, Inc. part of the worldwide BIOTRONIK group, a medical electronics manufacturer located near Portland, Oregon in the beautiful Pacific Northwest. We now have an opportunity for a Design Assurance Manager.
POSITION SUMMARY:
The Design Assurance (DA) Manager is a key leadership position that 1) participates as QA representative in the development life cycle of implantable pacemakers/defibrillators and the application programmers, 2) is responsible for the assurance that Design Control processes meet product expectations, 3) participates in developing strategic product planning to meet business growth goals, and 4) is responsible that MSEI System Design and Development fulfills Quality System requirements established by Biotronik GmbH and external Regulatory Agencies (FDA, TUeV, ISO). This position requires extensive knowledge of system engineering and design control concepts/technology as well as good understanding of computer science and electronics, as complex medical devices are increasingly controlled by ASICs, embedded firmware, and complex GUI driven programmer applications. Prior experience in the field of medical products and thorough comprehension of Medical Device Regulations (EU and FDA) is required.
RESPONSIBILITIES:
The prime responsibility is the assurance that Medical Products developed by MSEI meet or exceed all established criteria for those products during development and the product development lifecycle.
As the head of the DA team, this position assures the establishment and administration of the overall design control process, makes judgments on the sufficiency and adequacy of project plans, and details (as necessary) specific verification and integration efforts.
As head of the DA team, this position establishes effective Design Assurance disciplines and methodologies, and assures conformance to the Corporate Design Control protocols, and interacts internally and externally with Senior Management to report on the performance of those Quality Systems.
As head of the DA team, this position represents the MSEI product development process to external Quality System assessment agencies, where necessary.
As required, this position will develop and implement effective management and analytical strategies to assure technology, process, and product Requirements associated with MSEI developed products are sufficient for their purpose.
As delegated by MSEI Senior Management, this position will have decision making capacity in efforts related to Design Assurance and Risk/Safety/Mitigations planning and execution for MSEI product development.
As delegated by MSEI Senior Management, this position will review and provide Design Assurance approval of the application of the Biotronik Risk Analysis, Hazard Analysis, FMEA, and Mitigation measures processes to assure that the System Design is appropriate for the safety of the medical device.
As required, this position will lead the efforts and schedule/coordinate the progress of the verification/validation tasks.
As required, this position will review and provide DA approval of Subsystem/System Verification Plans and Verification Test Procedures for Hardware qualifications, Firmware qualifications, and/or Programmer qualifications appropriate to the user/patient REQs and RAN mitigations of the device.
As delegated by MSEI Senior Management, this position will perform local audit functions for the Corporation, to assure that Design Control Protocols are being followed. This may include Management Reporting to the Biotronik Quality Management group to assure management recognition of such status.
This position requires a high level of technical understanding with strongly demonstrated ability to make appropriate technical and value-added judgments.
This position requires a significant level of written/verbal communication skills, and requires high levels of interpersonal and team cooperation skills, including strong planning and execution background of qualification projects.
This position requires a significant level of influence management within a project Matrix organization, and ability to develop and execute concepts, ideas, and execution at broad levels of the management hierarchy.
POSITION REQUIREMENTS:
BS/MS/PhD degree in a technical Engineering discipline (e.g. System Engineering, Computer Science, Electronics Engineering) or Physical Science discipline (Physics, Molecular Biology, or Physiology).
At least one Master Degree is strongly preferred and a PhD degree is suggested; equivalent directly applicable work experience may be considered in place of advanced Degree.
Dual degrees in Computer Science and Electrical Engineering are desirable.
Experience:
15 years of technical experience in the design, qualification and system testing of medical device products, with an increasing and successful record of demonstrated judgment capabilities and successful product development lifecycles.
5 years of management experience in either the Design Assurance or Quality Assurance of medical devices.
++Added experiences: Expanded responsibilities of embedded software products and their interaction with Programming/Application software is a plus.
Experience in the medical products industry is very strongly preferred, but where significant responsibility in other high-tech industries of a similar nature is demonstrated, it may be considered in place of medical products industry background.
Specialized Skills:
Demonstrated ability to assess complex systems and drive value-based decisions relating to user needs, cost and time requirements
Demonstrated ability to work within a team, including excellent interpersonal skills
Demonstrated ability to decompose/understand System and Sub-System Architectures from overall System features and requirements
Demonstrated ability in Regulated Industry software design (preferably FDA regulated, FAA/MilSTD lesser alt.)
Demonstrated ability in Regulated Industry Design Control (preferably FDA regulated, CE-Mark/ISO Medical)
Experience in Regulated Industry Quality Systems, Quality Records documentation, and Audit practices to assure Design Control deliverables
Strong understanding of verification/validation processes,
Understanding, comprehension, and decision-making of experimental test design,
Experience with 8-bit/16-bit μController architecture,
Experience with 32bit Windows based applications,
Experience in Programming Languages (Assembly, C; C++/C#; Win32)
Experience with Test and Measurement instrumentation,
Understanding and application of Metrology principles of test measurement,
Understanding of modeling and simulation tools (e.g. MatLab, MathCad, Simulink, Rational Rose, Telelogic Tau)
Use of standard office applications (e.g. MS office), including MS Project (or other project mgmt tools)
Use of Configuration Management tools (e.g. MKS, PVCS, or ClearCase/ClearQuest),
Understanding of cardiac physiology, and heart rhythm management technology,
Self-motivated, self-directed, and the ability to learn quickly
For consideration please send your resume to:
careers@biotronik.com