Senior Biomedical Engineer- Electrical/Biomedical Engineer II - Electrical

Merz Pharmaceuticals USA•Franksville, WI

38d

About The Position

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics. An engineer, with an electrical engineering foundation, having at least 5 years of experience developing and sustaining regulated electro-mechanical device design and process, to support the Ultherapy medical device product portfolio.

Requirements

Bachelor's Degree in Electrical Engineering, Mechanical Engineering, other relevant Engineering discipline.
7+ years Electrical engineering experience in a heavily regulated industry (e.g., automotive, medical).
Printed circuit board design and analysis experience and understanding, including grounding/ EMI considerations.
Experience with Altium Designer or other electrical PCB design software.
Test of electro-mechanical and/or electrical system in a production environment.
Ability to articulate complex ideas to technical and non-technical personnel.
Strong technical and problem-solving skills.
Ability to formulate program strategy, budgets, and timelines.
Ability to communicate and write effectively.
Emotional self-management in difficult situations.
Understanding of process validation and statistical analysis.
Understanding and application of ISO 13485 quality management system requirements.
Understanding of FDA Design Controls and EU Medical Device Directive (CE Marking requirements).
Excellent project management skills, familiar with project management methods and tools.
Familiar with electro-mechanical manufacturing, depot service, and field service processes and operations.
Experience with system level requirements definition.
Knowledge and understanding of RF circuitry.
Understanding of Ultrasound.
Practical knowledge of Six Sigma methodologies. Green or Black Belt certification.
Experience with designing and implementing electrical solutions associated with cybersecurity standards and guidance for medical devices to meet regulatory requirements (e.g., UL 2900, TIR 57, FDA). Familiarity with security features such as hardware-based encryption or tamper detection mechanisms

Nice To Haves

Master of Engineering (M.Eng. or M.E.) Or other relevant Engineering discipline.
Electrical engineering experience in the medical device industry.

Responsibilities

Design and Development: Lead and manage complex activities related to maintaining and improving electro-mechanical medical device design, manufacturing, and service processes Participate in reliability studies. Support in troubleshooting activities, investigate the root cause to a successful conclusion, and help to resolve product complaints and CAPA
Prototyping and Testing: Conduct research and testing to solve problems. Test functionality, safety, and effectiveness. Develop prototypes and conduct testing to ensure devices meet customer needs, design requirements, and regulatory standards
Collaboration: Work closely with cross-functional teams, including systems engineers, mechanical engineers, process engineers, quality, and regulatory, to ensure device safety, compliance, compatibility, functionality, manufacturability, and serviceability. Mentor junior engineers
Regulatory Compliance: Ensure that device complies with relevant regulations and standards (e.g., FDA, CE Mark, IEC 60601 series, ISO 13485, GMP)
Documentation: Develop detailed electrical drawings. Documentation of design processes and test results. Execute the Engineering Change Order (ECO) process per Design Controls - Design Change regulations and internalâ¯policies. Support regulatory submissions