Summary of the position:
We are seeking a highly skilled and motivated Senior Associate to join our team. The ideal candidate will have extensive expertise in Design Control of Medical Devices, proficiency with Polarion or similar requirements management software tools, a strong background in systems engineering, and proficiency with Teamcenter PLM tool. This role will be pivotal in transforming and uplifting our Requirements, Standards and Risk management processes from paper-based to digitized states.
Key Responsibilities:
- Lead the transformation of Requirements and Risk management processes from paper-based to digital formats.
- Ensure compliance with Design Control regulations and standards for medical devices.
- Utilize Polarion requirements management software tools to manage and track requirements.
- Collaborate with cross-functional teams to ensure seamless implementation into the organization.
- Collaborate with cross-functional teams to drive harmonization and application of systems engineering principles.
- Develop and maintain documentation related to requirements, standards and risk management.
- Provide support and/or training to team members on the use of digitized tools and processes.
- Identify and implement process improvements to enhance efficiency and compliance.
Qualifications:
- Bachelor’s degree in engineering, Systems Engineering, or a related field.
- Minimum of 2 years of experience in Design Control of Medical Devices.
- Preferred Experience: +2 years associated with complex medical device design requirements and associated standards (e.g. SIMD medical devices)
- Proficiency with Polarion or similar requirements management software tools.
- Strong understanding of systems engineering and modeling principles and practices
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal skills.
- Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and customers
- Detail-oriented with a commitment to quality and compliance.
Knowledge, Skills and Abilities
Personal Effectiveness Competencies:
- Project Excellence - Intermediate
- Continuous Learning - Intermediate
- Digital and Technology Savvy - Intermediate
- Operational Excellence - Intermediate
- Breakthrough Analysis - Intermediate
- Organizational Savvy - Fundamental
Skills and Knowledge:
- Design Control - Requirements Management including design inputs and design outputs (V-model) Systems Engineering and Modeling
- STEAM – Applied Science, Technology, Engineering, Arts and Math
- Project Management experience
- Superior Excel and/or other database data analysis and visualization tools
- Regulations and Guidelines
- Excellent Technical/Scientific Writing in English in a regulated environment
- Superior verbal English communication skill (in a remote environment)
- Microsoft Office suite (i.e., Word, Excel, PowerPoint, Visio)
- Preference: Working knowledge of Subversion (SVN) version control
- Preference: Working knowledge of ReqIF formats
- Preference: Working knowledge of “state of the art” standard assessments
Experiences
- Cross Functional collaboration - Primary
- New Product Innovation - Secondary
- Accountability - Primary
- Influencing without Authority - Primary
- Managing Crisis – Secondary
- Functional Breadth - Secondary
Licenses and Certifications
ISO 13485 Training Preferred
ISO 14971 Training Preferred
IEC 62366 Training Preferred
Language Skills
Fluent English; excellent verbal and written communication skills
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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.
