Description: Principal Engineer (Systems Engineer) Medical Device related product development (surgical tools)
Summary: The Principal Engineer, Product Design - R&D, will be responsible for developing creative solutions to challenging issues associated with the design, development, and sustaining engineering for Microsurgery business. The successful candidate will possess solid technical abilities, project management abilities, and leadership skills, bringing excitement and energy for product development, a passion for their work, and the impact it has on meeting the needs of patients.
- Perform in the role of Lead System Designer, and managing technical execution of multiple new product development programs
- Lead and drive the R&D resources assigned to projects to meet or exceed project targets in schedule, budget, and quality
- Molding, over-molding, and micro-molding knowledge and experience preferred
- Lead Technical Reviews and be the lead R&D voice in Design Reviews
- Partner closely with Project Managers, Product Design Owners, and Quality Assurance
- Primary point of contact for the project technical deliverables and interface with cross functional teams, including Subject Matter Experts, Functional Managers, Project Management, and Senior Management
- Responsible for guiding cross-functional teams through device design control processes with responsibility for translating project objectives into execution and specification levels
- Expected to provide input to risk process, perform Engineering Investigations, and be a voice of knowledge for process development, problem solving, issue resolution and risk mitigation
- Directs teams in the determination of acceptability of correction, as assigned - corrective and preventative actions by considering impacts on performance, safety, costs, fielded product, manufacturing, and other factors
- Anticipates potential conflict situations and proactively proposes solutions and resolves conflict situations, project bottlenecks as they arise, negotiating effectively with project teams
- Prepares project reports, analyses and delivers presentations to leadership as requested
- Provide scheduled written and verbal status to manager and R&D teams as needed
- Manage and nurture partnerships with 3rd party developers and work with external IP holders in turning ideas into manufacturable and marketable products
- Ability to work within multiple quality systems between vendors and Client with confidence and provide stability in the translations between organizations
- Independently plan, schedule and lead R&D team in detailed phases of the engineering work in a project
- Coaches team members to ensure process adherence, technical design and delivery, utilizing best design and development practices and project management skills
- Facilitates communication within assigned resources for execution tasks, owns and follows up on all assigned deliverables
- Provides feedback to functional department heads during strategic planning and the performance management process
- Actively identifies and manage risks and issues through problem avoidance, contingency plans and proper escalation
- Demonstrated success leading root cause analyses and implementing corrective actions (CAPA)
- Knowledge and experience in test method development and validation Ability to exercise independent judgment and draw conclusions based on available information
- Demonstrated experience with medical product development
- Completely proficient in relevant product and process development processes
- Recognized as a technical expert by peers and management
- Ability to organize and present technical and project management overviews without assistance
- Demonstrated success in delivering results on several technical challenges
- Demonstrated strong process optimization and analytical skills
- Proven ability to create results within budget, timeline, and deliverables Self-motivated with good interpersonal skills, must be able to simplify the complex and speak to difference audiences
- Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards
Education / Experience:
- Bachelors of Science in Engineering (discipline: Mechanical, Biomechanical, Biomedical Engineering preferred)
- 5 - 8+ years recent and relevant work experience in a medical or regulated industry (prefers 8+ years of experience)
- Medical product design experience required
- Experienced with all typical software tools (MS Office Suite, Minitab, CAD SW - prefer SolidWorks).
- Must have experience or advanced training and demonstrate proficiency with CAD, TQM, statistical methods, problem analysis, and resolution, materials science, and design of experiments.
- Also needs to understand System Engineering tools to manage requirements (e.g. DOORS, etc)
- Extensive cross-functional team experience, including technical and non-technical work
- PHYSICAL DEMANDS
- Regular attendance is necessary to perform the essential functions of the job.
- Sedentary work, lifting a maximum of 20 pounds; walking / standing occasionally.
- Normal office working conditions: computer, phone, files, fax, copier.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178
Complex Problem Solving
New Product Development