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Werfen, founded in, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Position Summary:
Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Plans and conducts work requiring the application of extensive and diversified knowledge of engineering principles in broad areas of assignments and related fields. Generally, uses advanced techniques and the modification or extension of theories, concepts and practices in the specialty and/or related disciplines. Maintains a clear overview of a major product development. Makes sound judgments when compromises, necessitated by available time and technical capacity, must be made to meet set objectives. Mentors junior staff.
Responsibilities
Key Accountabilities:
Essential Functions:
* Acts as an individual contributor, core team member, or technical lead for a specific project or product line.
* Responsible for completing assigned deliverables according to schedule.
* Authors documentation and supports design control activities.
* Plans, performs, and prioritizes complex tasks aligned with corporate goals.
* Analyzes data, identifies trends, and formulates next steps, including trade-off analysis.
* Leads the design and development of test methods, specifications, technical apparatus, software, and processes for complex components.
* Evaluates designs or processes for acceptability, suitability, and cost; recommends optimal options and presents trade-offs.
* Identifies product defects, recognizes outliers, and documents defects and their impacts.
* Communicates technical information effectively to multidisciplinary teams through documentation, presentations, and summaries.
* Possesses expertise in multiple areas or is a subject matter expert in at least one.
* Leads without authority, providing guidance and mentoring to engineers and technicians.
* Supports or leads CAPA or complaint investigations.
* Creates schedules for activities, understanding cross-functional dependencies.
Secondary Functions:
* Reviews and provides input on deliverables from other functions.
* Recommends improvements and motivates implementation.
* May own CAPA processes.
Budget Managed: N/A
Internal Networking/Key Relationships:
Interacts with various organizational groups as needed.
Skills & Capabilities:
Electrical Architecture:
* DSP & Firmware Development Engineer
* Board level Circuit Design and construction
Technical Experience:
* FPGA – 5-10 years in design and implementation, or embedded DSP software
* High-level digital/analog signals – understanding of circuits, component selection, debugging
* Control systems – design and management
* System-level root cause analysis
* Simulation models and hardware implementation
* Noise/EMI/EMC compliance and testing
* Power electronics and distribution
Leadership:
* Product lifecycle experience, from concept to launch
* Project leadership experience
* Technical complexity, modular, and system integration skills
* Effective communication at the program level
* Technical reporting and proposal support
* Independent, analytical, and methodical
* Continuous learning and innovation
Computer Science Background:
* C, C++, Python
Nice to Have:
* Wireless, RF, People Management
Qualifications:
Minimum Knowledge & Experience:
* Bachelor's in Engineering, Science, or related field
* 12+ years product development experience; 8-10 years for advanced degrees
* Internal candidates: proven proficiency and performance may suffice
* Experience with in vitro medical devices highly desired
Additional Skills/Knowledge:
* Proficiency in English
International Mobility: Not required
Travel Requirements: Some domestic and international travel possible
If you are interested in constantly learning and being challenged daily, we encourage you to submit your resume or CV.
Werfen values diversity and is an Equal Opportunity Employer. We operate in over 30 countries with an annual revenue of approximately $2 billion, employing over 5,000 people worldwide.
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