Job Description Summary

Job Description

Professional Experience

• 16+ years of product development or product life-cycle experience in Medical Device and/or pharmaceutical industries is required.
• Minimum 6 years of experience directly leading product engineering teams (15+ members) in a cross functional environment in medical devices, pharmaceuticals or life sciences is required.
• Proven ability to recruit, build talent and nurture teams through various milestones in a regulated environment to deliver solutions predictably on time, at cost and with quality is required. Ideally this experience would have been acquired in a fast paced, dynamic and delivering high volume, disposable product environment.
• Prior successful experience in a global, matrix environment with experience in material changes, driving cost reductions, notified body interactions and budgetary responsibilities is required.
• Demonstrated ability to guide and mentor teams in solid works and other CAD/CAE tools, expertise in DMAIC/DFSS using Stata, R, SPSS, or relevant statistical package is necessary.
• In-depth understanding of various design tools used in requirement flow-down, tolerance analyses, loop-equations, FMEA, SPC and risk-retirement is required

Demonstrated ability to lead via influence, to motivate and nurture a team-spirit and to create a boundary less team culture is required.

• Strong verbal and written communication skills, with the ability to adapt style/tone/tenor to various levels of the organization is required.

Job Responsibilities

• Conceptual thinking: Uses original or out of the box thinking to come up with solutions to complex problems independently and actively engages other experts
• Conflict Management: Know when conflict (scope, timing, resources) is preventing progress and when to act; Proven track record of dealing with organizational conflict appropriately and effectively.
• Influencing Others: Has learned how to "sell" a concept to gain support; Proven track record of influencing cross functional leaders to solve problems and remove roadblocks
• Fostering Teamwork:
• Leads the organization by setting focused and measurable objectives (monitoring and continuously evolving objectives to ensure a "win")
• Identifies potential issues and proactively addresses to avoid if possible or mitigate if realized
• Proactively resolves team conflicts
• Chooses success over "being right" and leads team members to achieve a common goal.
• Proactively communicates status, issues, mitigation, and achievements to key stakeholders and actively manages stakeholder expectations
• Foster and sustain a culture of collaboration, inclusiveness, curiosity, and agility.
• Ownership:
• Ownership of my team impact and contribution to business
• Able to identify the end line for each task with minimal direction or supervision
• Able to lead cross-functional teams owning the deliverables of the team
• Technically capable to develop technical rationales with no direction or oversee
• Proactively looking ahead and removing roadblocks.
• Strategy:  Understand supply chain, forecasting and business cases behind projects. Represent the function on portfolio level prioritization discussions.  
• Competitive Landscape: Ensure in depth research and assessment of the industry landscape from IP, regulatory, products, technologies standpoint.
• Quality and Compliance: Hold self and team accountable to best practices in Design Control for medical devices and ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.

Knowledge

• Medical Devices Domain Knowledge
• People Manager Experience
• ISO13485 and other standards

Skills

• Strong interpersonal and influence skills.
• Strong written and verbal communication skills.
• Advanced Problem-solving skills.
• Strong Cross functional Project Leadership skills.
• Strong technical and managerial judgment.
• Team orientation.
• Strong skills in project planning and management.
• Broad and deep understanding of disciplined change control processes, regulatory, and quality requirements.
• Strong motivational fit.
• Strong fit with BD values.

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift