
Owner, NJK & Associates, Inc.
Greater San Diego Area

Owner, NJK & Associates, Inc.
Greater San Diego Area
Medical device consultant with extensive experience in device ideation, design, development, manufacturing, and quality. Particular expertise in problem solving for internal, customer, and agency issues related to products, processes, and interactions.
Creation and implementation of new quality systems for medical device and IVD companies. Preparation of regulatory submissions. Remote hosting of quality systems documentation and doc control. Quality auditing. New product ideation, design, development, prototyping. Experience in consumer products, surgical instruments, optical devices, infusion pumps and plumbing, implantable devices...
(Self-Employed; 1-10 employees; Medical Devices industry)
February 2007 — Present (1 year 9 months)
Quality and regulatory consultants to medical device and IVD companies. Development and implementation of complete quality systems, regulatory submissions, international submissions, contract auditing, document control, manufacturing engineering, new product ideation, failure investigation, product development.
(Sole Proprietorship; Myself Only; Photography industry)
2000 — Present (8 years)
Dog Agility and Equestrian action photography.
Industrial photos - process descriptions and work instructions, failure investigation, marketing materials.
The occasional wedding or bar mitzvah too!
(Public Company; 1001-5000 employees; Medical Devices industry)
2000 — 2007 (7 years)
Quality Assurance, problem solving, internal consultant on infusion systems & disposables, failure investigation
(Medical Devices industry)
2005 — 2007 (2 years)
(Privately Held; 11-50 employees; Medical Devices industry)
1999 — 2000 (1 year)
I was responsible for collaboration in the creation of new surgical instruments, from the first concept and line on paper to rapid prototypes and working models.
(Medical Devices industry)
1997 — 1999 (2 years)
(Medical Devices industry)
1989 — 1996 (7 years)
(Medical Devices industry)
1987 — 1989 (2 years)
(Public Company; 10,001 or more employees; EK; Research industry)
1975 — 1987 (12 years)
Spectrophotometry lab, developed novel spectrofluorometer, testing methods development for sensitized products, color stability testing
MS, Optics, 1974 — 1975
BS, Physics, 1969 — 1974
Co-op research assistant for Pete Hansen developing optical tissue measurement system. Research with Van Anastassakis on optical properties of crystals w/temperature, pressure, electric field.
Regents, 1966 — 1969
Failure investigation, risk management, usability, problem solving, product ideation, digital photography, horses, dog agility
NAPP
Sigma Xi,
Patents:
7,322,933
7,256,888
7,227,630
7,190,990
6,856,458
6,816,262
6,745,067
6,685,630
6,668,186
6,411,434
6,360,115
6,330,106
6,163,377
6,023,289
6,020,917
5,995,867
5,978,695
5,800,445
5,700,236
5,697,943
5,658,236
5,626,588
5,620,456
5,616,131
5,584,793
5,573,493
5,569,160
5,562,694
5,562,686
5,543,832
5,507,757
5,503,635
5,496,341
5,467,762
5,441,041
5,431,666
5,368,601
4,675,755
4,384,238
4,345,825
4,302,084