Senior Product Line Engineer for our Vascular Access Business Unit
Duties and Responsibilites
- Interact with customers, clinicians, and business stakeholders to document clinical/market needs and the competitive landscape
- Works on roadmap for the Vascular Access PIVC business unit
- Creates innovative concepts that support the strategic initiatives and conducts feasibility studies supporting proof-of-concept
- Requirements definition (e.g. customer requirements, product specifications, system specifications, etc.)
- Vertical/product standards management and subject-matter expertise
- DHF creation and management
- Ensure maintenance, safety, efficacy and compliance of existing product lines
- Does customer visits and visits trade shows as means of collecting requirements for future device developments
- Ability to plan, develop, manage, and track work stream deliverables and detailed design work packages
- Devises innovative approaches to complex problems as encountered.
- Is technical leader on major projects and provides guidance and direction to engineers and/or technicians for the duration of project. Works with vendors and internal departments to provide technical direction, obtain necessary resources, resolve inter-departmental issues, and contribute toward project and organizational objectives.
- Performs high level engineering work requiring recognized expertise in this discipline of engineering. Plans and oversees work requiring judgment in the independent evaluation, selection and the substantial adaptation of standard engineering techniques, procedures and criteria.
- Oversees and participates in engineering projects and development activities of significant scope or degree of difficulty. Determines project parameters and assignments for project groups. Performs projects with only general supervision.
- Plans and schedules engineering effort for all assigned projects and monitors progress to schedule.
- Reviews and guides the resolution of technical issues as needed and ensures that technical work meets requirements and specifications.
- Creates or contributes to specifications and project plans.
- Assures engineering activities including documentation proceed per requirements of Standard Operating Procedures.
- Maintains frequent communications within and outside of department in support of engineering activities, such as project management meetings and material review, etc.
- Guides the decision-making process; frequently conducts the meeting or presentation, and makes follow-up assignments to team members.
- Coordinates communications with vendors to provide technical information and expertise as well as technical issues.
- Plans and assigns work / project tasks / responsibilities to personnel (typically technicians and engineers assigned to the specific project). Has no direct subordinates; but provides functional supervision to project team members for the duration of project assignment.
- This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, ISO13485, ISO14001, OHSAS18001 Health and Safety regulations, government occupational health and environmental regulations and statutes).
- Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
Required Skills andExperience
- Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering or similar with 9-12years of experience or 5-8years with an advanced degree.
- Applies extensive technical expertise in the engineering field and has full knowledge of other related disciplines (GPM, RAQA, Sales and Ops)
- Prior experienceworking with single use disposable medical devices such as catheters desirable
- Working knowledge in SolidWorks CAD package
- Experience with Statistics, preferably with Minitab
- Working knowledge of: Microsoft Office tools, Visio and MS Project
- Proven ability to lead, establish, maintain and influence effective working relationships with internal and external customers across functions.
- Driven and high energy that can get things done
- Ability to work with integrity and build trust.
- Advanced problem solving and analytical ability.
- Ability to critically review and interpret technical documentation.
- Ability to work accurately with attention to detail.
- Ability to handle multiple priorities and to meet key deadlines under pressure through effective time management skills
- Ability to clearly convey ideas and concepts verbally and in writing.
- Proven ability to coach and mentor others in technical matters and customer needs.
- Ability and willingness to lead and create change – changes in policy, procedure, technology, and culture.
- Ability to plan and conduct effective meetings and group presentations.
- Strong influencing skills and ability to provide functional supervision to project team members as required
- Strong organizational skills
- Strategic ability with regards to trade-offs in designs and between multiple project needs.