Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, Minneapolis, San Francisco, Silicon Valley and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products. We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.
Position: The experienced Mechanical Engineering Manager supports our domestic and international product development, sourcing, and manufacturing business.
Nature of Role: The Mechanical Engineering Manager is a key leadership position reporting to the Director of Engineering. The position has two primary objectives. First, the role provides management, leadership and independent review of work completed by engineers assigned to various project teams. The Mechanical Engineering Manager will directly manage a portion of the mechanical engineering team as well as provide leadership and guidance to members outside of his/hers reporting structure. Secondly, this individual may be a mechanical engineering lead on product development programs. This entails leading activities through all phases of the medical product development process. This includes conceptual design, detailed engineering, participating in design verification, validation, and manufacturing transfer. As appropriate, the manager will also ensure compliance with medical device regulations and device standards in this regulated industry.
Responsibilities: The manager is responsible for advising teams and following Ximedica’s processes and procedures related to product development, including but not limited to:
- Provides technical guidance to Mechanical Engineers and cross-functional development teams
- Conduct performance reviews and develop individual employee professional development plans for direct reports
- Leads and mentors mechanical engineers while providing employee development and teambuilding.
- Works with the Director of Engineering to monitor the capacity of the staff directly reporting to the role
- Acts as independent reviewer at key points in programs, including technical reviews, phase reviews and risk management reviews as well as advising on potential corrective action.
- Provide technical review and participates in milestone reviews within the product development cycle, to ensure customer and user requirements
- Ensures adherence to established development policies and procedures, targeting reproducible and high-quality output by participating in the overall program and development process
- Participate in sales activities, including reviewing proposal content and attending sales calls, as necessary
- Further advises Program Management on schedules and risks which may affect delivery timetables on assigned projects and technical reviews
- Works with the Director of Engineering to determine a department budget and execution of personnel training and tool inventory to ensure proper discipline capability
- Employs/applies/develops standard development methodology and best practices
- Participates in the recommendation, implementing and/or overseeing new technologies to insure Ximedica is a leader in hardware development
- Maintain duties and responsibilities of a Lead Mechanical Engineer on programs as needed
- Participate in the establishment of departmental best practices and other continuous improvements, including SOP’s
- Work with the Director of Engineering to identify and build relationships with independent contractors suitable for development engineering assistance, both in general and with specific expertise
- Participate in ‘on-boarding’ of new employees; educate new and existing employees on the entire development process
Requirements: An effective leader preferably holding a BSME degree coupled with 10+ years of mechanical engineering experience within the medical device/equipment industry. Possess a solid background in the design engineering, manufacturing and sourcing of electromechanical components. The ability to prototype, simulate, debug, and test systems is required. A minimum of 2 years in leading technical teams including indirect personnel is required. Knowledge of FDA QSR Regulations (21 CFR 820), ISO 13485 (Quality System) and ISO 14971 (Risk Management) is essential.
Our fast-paced environment demands the ability to manage multiple projects within the discipline and deadlines. High-energy, self-starters with the following qualities:
- Must be able to oversee, manage, coordinate and prioritize the activities of a portion of the Mechanical Engineering staff.
- Excellent communication skills, business acumen and assertive decision-making ability. Must be able articulate complex problems effectively to both internal and external stakeholders
- Flexibility to multi-task and perform a wide range of activities
- Excellent mechanical product development skills including, mechanical design, material selection, quantitative analysis, instrumented testing and basic statistical skills.
Excellent computer skills including, CAD, FEA, data processing, and presentation skills.