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Director of Operations
200 W. Mercer Street Seattle, WA 98119 US
Job Description
Job Responsibilities:
Operations
- Define, develop and execute overall operations, manufacturing and support of logistics capabilities.
- Own communication of overall operations/manufacturing strategy and on-going results to all internal as well as external customers.
- Lead the structuring, recruiting, on-boarding and management of new team members within the Operations and Manufacturing teams based on the successful growth of the business
- Manage project team resources effectively and support applicable task and milestone objectives.
- Support implementation and ramp up of ERP systems and management activities.
- Collaboration with the Sales, Clinical Operations, Product Development and Business Development to set and measure progress against overall business goals
- Work closely on R&D for future product roadmap initiatives
Contract Manufacturing
- Act as the primary interface with our contract manufacturer(s) for all functions including forecasting, production management, assembly process improvement, cost optimization, implementation of part modifications/manufacturing process changes, etc.
- Manage and coordinate personnel at company and its CDMOs to ensure production plans, product supply and quality standards are met
- Negotiate and drive cost reduction initiatives at CDMO’s and 3rd party vendors.
- Ensure productive, safe and compliant cGMP operations.
- Manage cross-functional teams including ME, Quality, PD, Analytical, and Supply Chain working with company’s CDMOs
- Lead tech transfers of new processes to CDMOs, as required
- Manage creation, editing, and execution of SOWs and Change Orders controlling CDMO production
- Lead relationship management of company’s CDMOs, including CDMO governance, Executive meetings, Leadership Team, and other inter-company meetings, as required
- Manage the payment process (Purchase Orders, Invoices, and Quarterly reconciliations) associated with CDMO production
- Contribute to the business results through quality of decisions, results and advice
- Contribute to development and implementation of metrics to track and manage successful, timely accomplishment of assigned goals, objectives and projects
- Support all supplier management activities including SCARs, managing audits and other quality activities for a spectrum of component suppliers (molded parts, trays, Tyvek lids, etc.)
New Product Introduction
- Define and lead the process to identify, engage and solicit proposals from potential contract manufacturing partners
- Direct and oversee requirements for process development and validation initiatives (IQ, OQ, PQ, sterilization, etc.)
- Direct and oversee requirements for manufacturing strategy planning and implementation into high volume CDMO manufacturing
- Direct Manufacturing Engineering on manufacturability assessments (COGS target, ROI assessments, PPM requirements) for product development and cost reduction projects.
- Evaluate the implications of incorporating various levels of assembly automation based on analysis of financial considerations (NRE vs. COGS reduction opportunities)
Logistics/Distribution
- Oversee the contract manufacturer and 3PL management of all logistics from assembly to end customer fulfillment
- Oversee transition of post-production warehousing and distribution to a 3PL and distribution to end customer.
- Oversee inventory management and distribution costs.
- 10+ years of experience in operations and manufacturing, including high volume, low cost injection molded medical devices
- 5+ years’ experience in a management position, device manufacturing with CDMO’s highly preferred
- Experience directing medical device manufacturing operations and leading Manufacturing Technical Support for both internal and CDMO operations
- Experienced with managing contract manufacturers and 3PL networks.
- Bachelor's Degree required; Master's Degree preferred.
- Strong background and experience developing staged growth and manufacturing plans for introduction of new products (from proto to low/med to high volume)
- Demonstrated expertise in competitive supplier selection/RFP processes
- Broad experience working within medical device quality systems
- Experience with successful implementation of Lean Manufacturing principles and practices.
- Exceptional analytical skills and results-orientation; experience developing, tracking and reporting KPIs and other metrics that demonstrate progress against goals for operations/manufacturing
- Strong written and verbal communication skills; passion for continual improvement and willingness to evangelize your ideas and concepts to all relevant members of the team
- Earnest desire and commitment to work in a startup environment
- Global experience preferred.
Job Details:
- Direct Hire
- Salary range: $175-230K
Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.
Meet Your Recruiter
Jeff Morgante
I have been working in technical staffing since 2010, specializing in recruiting hardware, software, electrical, and mechanical engineers. My recruiting style is personal, where I understand the technology and can communicate with engineers on all levels with an engineering background myself, I can relate and communicate using the same language.
Finding an excellent fit for engineers is why I love recruiting; I can help you achieve your career goals and job transitions and find the perfect fit for you. My philosophy is “never give up”. Outside of work, I like to put my energy into listening to vinyl records, hiking, and cooking. I have two dogs, Kaleb and Kayce, and two cats, Mika and Shiloh. I am originally from upstate New York, but I love living in the Pacific Northwest! I have a passion for cars, old and new, so finding common ground is easy for me. Let’s get started today!