Staff Product Engineer
Business Unit: Point of Care
Requisition Number: 228241
Primary Location: United States-Massachusetts-Norwood
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
The Product Engineer will help the team design, develop and commercialize new Point of Care products. The talented and passionate individual will be responsible for planning, designing, analyzing, developing, testing, and documenting mechanical, fluidic and electromechanical components and systems for use medical diagnostic instruments. In addition to technical expertise, the Product Engineer will bring strong leadership and team building skills and foster an environment of growth and personal development.
Duties & Responsibilities
• Lead mechanical design of system items and consumables, including prototypes, tooling and test fixtures, and support development of manufacturing equipment and processes
• Conduct data acquisition, analysis and statistical techniques using Labview, MatLab, Minitab etc.
• Lead efforts in creation of specifications and test methods for new products
• Work with upstream and downstream stakeholders to create designs that meet customer expectations and manufacturing requirements
• Use first principles and advanced engineering methods to guide the development process
• Perform 3D modeling and tolerance analysis of complex electromechanical systems
• Perform design reviews, FMEA’s, risk / hazard analysis, establish technical requirements
• Identify and qualify suppliers for specialty materials and equipment
Knowledge & Skills:
• Strong design skills with mechanical components and assemblies
• Proficiency with data acquisition, analysis and statistical techniques using Labview, MatLab, Minitab etc.
• Experience in fluidics and designing small fluidic systems
• Demonstrated understanding of product development considerations for tightly controlled manufacturing processes
• Clear understanding of product and process validation including V&V, TMV, FAI, FAT/SAT IQ/OQ/PQ etc.
• Excellent understanding of medical device product development risk management methodologies
• Knowledge of Design of Experiments (DOE), Design for Six Sigma (DFSS), Design for Manufacturing/Assembly (DFMA)
• Ability to clearly communicate ideas and knowledge (upward and downward) to other individuals and teams - both in writing and verbally
• Ability to manage competing simultaneous priorities effectively
• Basic understanding of IP considerations
• Expert capability with SolidWorks
Education & Experience:
• MS in Engineering (Mechanical preferred) with at least 5 years experience, or other Engineering degree plus 8 years experience as a Mechanical product design / development engineer and/or project engineer in the medical device or pharmaceutical industries
• Completion of multiple projects within a structured Phase Gate development environment through all phases of the Design Control process
• Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes
• Experience designing components for high volume manufacturing processes, i.e. injection molding, extrusion, metal stamping
• Strong project management and experience working with outside design services, including managing budgets, timelines, design scope and manufacturing activities
Additional Preferred Qualifications:
• Familiarity with materials used in medical devices (best practices, biocompatibility)
• Specialty technical expertise, such as materials related to medical plastics or lubricants, or the use of Computational Modeling and Simulation tools for fluid or structural/solid mechanics
• Hands-on ability to work on test method development, fixture development, prototype assembly, preliminary concept generation testing/evaluation
• Experience leading cross-functional teams
• Proficiency in Microsoft Project or equivalent project planning software