Summary
The Associate Staff Engineer is a technical leadership role who will own, lead and support the
end-to-end Design and engineering deliverables and solutions for high-volume medical device
products right from Design and Development to Verification and Validation activities. (S)he,
working with the local and global stakeholders, will deliver relevant solutions to new and existing
products through design calculations, risk-retirement using first principles engineering,
technical analyses and verification of the design. The Associate Staff Engineer will learn and
ant
engineering tools to deliver a high quality, robust and cost-effective design and will partner
cross-functionally to execute all aspects of product development. They will also ensure
successful design-transfer into manufacturing.
Educational Background
Full time Degree in a relevant engineering field is required (i.e., Mechanical, Industrial &
Production, Chemical, Materials Engineering)
Masters and PhD in Engineering is highly preferred.
Professional Experience
Minimum 12 years of experience in engineering/technical field, with 3 years demonstrated
project and team leadership, preferably in the medical device industry with successful track
record of project completion.
Job Responsibilities
Own, Lead, Mentor, and coach project team(s)in all technical aspects of projects/ programs
of diverse medical devices under the respective platforms
Identify the best tools and approaches to effectively solve engineering problems to
develop/optimize designs by leveraging appropriate mix of first principles / analytical,
computational, and experimental methods.
sharing sessions.
Drive initiatives of the organization that would enable technical excellence.
Lead and ensure implementation rigor of design control best practices with compliance to
BD quality policies and procedures through appropriate communication, training, and
education of sound quality assurance principals.
Ensure compliance with all local, state, federal, and BD safety regulations, policies, and
procedures.
Lead and own the design efforts over the continuum of product development and/ or life
cycle management/ Sustenance engineering / NPD Projects.
Remove obstacles and provide technical direction and mentorship to Design, Development
and Verification Validation Teams.
Should be able to do project management and review various projects and programs. Own
the project priorities and ensure timely completions.
Coordinate with the cross-functional teams (i.e., Marketing, Quality, Supply chain,
Regulatory, Manufacturing Technology, Operations, Cytotoxicity, Sterilization teams etc.)
to deliver the design solutions.
Develop technical design and/ or verification documentations, draft engineering and test
plans, drawings, 3D models as needed independently or with team basis business
requirements.
Should be able to effectively interact and communicate with global teams across BD.
Own the design and/ or verification deliverables of the project assigned.
Develop, verify and validate test methods and prototypes as needed.
Execute Risk Management activities to ensure that design and process shortcomings are
identified and appropriately addressed.
Optimize product design, material selection, product features, process design and humanfactor
need based on the project needs.
Drive the right culture in the organization in line with BD Values. Work closely with functional
managers for resource managements and feedbacks.
Analyze the design and utilize robust engineering principles to ensure that the design is
optimized to satisfy product and business requirements.
Ensure the design considerations are embedding all applicable DFX (Design for
Excellence) aspects including manufacturability, serviceability, reliability and safety.
Create solutions for technical problems using systematic problem-solving methodologies
and engineering principles such as DFSS.
Drive meetings and collaborate with various stakeholders to operationalize the programs
and projects.
Organizational Leadership
Quality systems processes: Drive best practices in implementation of quality systems
processes including design controls and change control.
Technology transfer: Ensure efficient and effective transition from research to development
to manufacturing in locations throughout the world
Process effectiveness: Develop and implement appropriate processes for effective and
accurate execution of engagement of other parts of the company in project activities.
Innovation: Develop and apply innovative approaches to ensure best outcomes in all
aspects of the role. Support an environment in which innovation can flourish through
empowerment, encouragement, and support.
Influence others: Intuitively and quickly assess people and situations and act accordingly.
Demonstrate strong persuasion and timing skills. Remain open to be persuaded when
appropriate.
Inclusive work environment: Promote and leverage diversity to achieve best outcomes.
Leadership courage: Demonstrate and promote leadership courage by doing what is right.
Engage those who disagree to persuade or be persuaded. Instil confidence in associates
and customers.
Dealing with ambiguity: Demonstrate agility and action orientation when facing change and
uncertainty. Effectively manage change and instil confidence.
Organizational Development
Proactively develop, maintain & share technical knowledge in specialized area(s),
remaining up to date on current trends and best practices.
Actively lead, mentor, and motivate team members and junior associates, while also
ensuring effective cross-functional communication and engagement
Develop and apply innovative approaches to ensure the effective capture, retention and
communication of technical and project knowledge generated (tacit & implicit).
Knowledge
Demonstrated first principles engineering and design skills
Exposure to six sigma and lean methodologies is highly desirable. Candidates
with prior experience in Medical Devices will be preferred.
Experience in CAD/CAE tools (Solid Works, AUTOCAD, PRO-E, etc)
specializing in mold flow, structural designs, CFD, statistics and advanced
statistics and plastics domain is desired.
Experience with implementing product changes through a structured, phasegated,
product development process is desired. Good understanding of
medical device product development risk management methodologies (EURA,
FMEA, etc.) will be an added advantage.
Ability to analyze, organize and present large amounts of data in a clear and
concise manner.
Disciplined, detailed and well organized with managing documentation in a
regulated environment.
Ability to execute concurrently multiple projects and manage priorities.
Ability to work independently with global exposure is desired.
Experience in medical devices will be highly preferred.
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.
Primary Work Location
IND Bengaluru - Technology Campus
Additional Locations
Work Shift
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